Warning Letters

 
FEI NumberLegal NameStateCountry/AreaProduct TypeAction Taken DateAction TypeCase/Injunction ID
3017569510QUALITY CDMO, Inc.TexasUnited StatesDrugs2024-09-11 00:00:00Warning Letter665961
3018061317Aromas Para El Alma S.A.-Costa RicaDrugs2024-09-10 00:00:00Warning Letter672728
3027541118Mid Link-ChinaDevices2024-09-10 00:00:00Warning Letter687111
3008943787Sanitation & Environmental Technology Institute-ChinaDevices2024-09-10 00:00:00Warning Letter687970
3011214285EnviroServe Chemicals & Cleaners Ltd.-CanadaDrugs2024-09-09 00:00:00Warning Letter674090
3014583374Avaria Health & Beauty Corp.-CanadaDrugs2024-09-03 00:00:00Warning Letter685248
3030093357Root Bioscience, Inc.North CarolinaUnited StatesDrugs2024-08-30 00:00:00Warning Letter673646
3010999645Orean Personal Care Ltd-United KingdomDrugs2024-08-29 00:00:00Warning Letter682813
3013712903Zydus Lifesciences Limited-IndiaDrugs2024-08-29 00:00:00Warning Letter685224
3030378326Naturistas Especializados-MexicoDrugs2024-08-27 00:00:00Warning Letter682383
3030379079Al Natural eShopCaliforniaUnited StatesDrugs2024-08-27 00:00:00Warning Letter682383
3031206650MexHealth LLCCaliforniaUnited StatesDrugs2024-08-27 00:00:00Warning Letter682383
3030905367SoloVitalCaliforniaUnited StatesDrugs2024-08-27 00:00:00Warning Letter688046
3016957698EVERYMARKET INCMissouriUnited StatesDrugs2024-08-27 00:00:00Warning Letter688348
3010164449AnuMed International LLCArizonaUnited StatesDrugs2024-08-20 00:00:00Warning Letter674310
3030431122Mother Stem InstituteFloridaUnited StatesBiologics2024-08-20 00:00:00Warning Letter680118
3014137184J. Robert FlaminiGeorgiaUnited StatesDrugs2024-08-20 00:00:00Warning Letter691123
3021091668Kaylaan LLCNew YorkUnited StatesDrugs2024-08-19 00:00:00Warning Letter681977
1000307669Regenerative Biologics Inc.FloridaUnited StatesBiologics2024-08-16 00:00:00Warning Letter672154
3011320041Regenerative Processing Plant, LLCFloridaUnited StatesBiologics2024-08-16 00:00:00Warning Letter672154
1000122754Accupack Midwest IncOhioUnited StatesDrugs2024-08-15 00:00:00Warning Letter680228
3008461619Eugia Pharma Specialities Limited-IndiaDrugs2024-08-15 00:00:00Warning Letter681905
3027059496MEDIA NETWORKS SYDNEY PTY LIMITED-AustraliaDrugs2024-08-15 00:00:00Warning Letter687044
1720129Optikem International, Inc.ColoradoUnited StatesDevices2024-08-13 00:00:00Warning Letter683606
2516287Greco Gas, Inc.PennsylvaniaUnited StatesDrugs2024-08-12 00:00:00Warning Letter683090
3030405443Moyeah Store.comCaliforniaUnited StatesDevices2024-08-08 00:00:00Warning Letter677092
3011278773Natures PillowsPennsylvaniaUnited StatesDevices2024-08-07 00:00:00Warning Letter676849
3030414279Leel Tech-ChinaDevices2024-08-07 00:00:00Warning Letter677297
3005350897Belleview 402 LLCFloridaUnited StatesDrugs2024-08-06 00:00:00Warning Letter683081
3002657228LS Promotions Inc.New YorkUnited StatesDrugs2024-08-05 00:00:00Warning Letter685889
3006948427Z-SYSTEMS AG-SwitzerlandDevices2024-08-02 00:00:00Warning Letter689419
3006010954Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd.-ChinaDrugs2024-08-01 00:00:00Warning Letter675823
3020703259Carsgen Therapeutics CorporationNorth CarolinaUnited StatesBiologics2024-07-26 00:00:00Warning Letter686504
3030575346Matte BeautyFloridaUnited StatesDrugs2024-07-25 00:00:00Warning Letter679463
3016994737Amazon.com, Inc.WashingtonUnited StatesDrugs2024-07-25 00:00:00Warning Letter679523
3030599243Isis.GoldIllinoisUnited StatesDrugs2024-07-25 00:00:00Warning Letter679948
3030604996Repare SkincareMassachusettsUnited StatesDrugs2024-07-25 00:00:00Warning Letter680247
3030830526Skin Beauty Solutions IncMinnesotaUnited StatesDrugs2024-07-25 00:00:00Warning Letter683006
3014706754Walmart Fulfillment KY1 9074KentuckyUnited StatesDrugs2024-07-25 00:00:00Warning Letter683095
1120890Aerosol and Liquid Packaging, Inc.MarylandUnited StatesDrugs2024-07-24 00:00:00Warning Letter676746
3005274476Omega Tech Labs, LLCIdahoUnited StatesDrugs2024-07-23 00:00:00Warning Letter679700
3005670221Jiangsu Caina Medical Co., Ltd-ChinaDevices2024-07-18 00:00:00Warning Letter687033
3003902757Jiangsu Shenli Medical Production Co., Ltd.-ChinaDevices2024-07-18 00:00:00Warning Letter687035
2000044401Velocity Pharma LLCNew YorkUnited StatesDrugs2024-07-17 00:00:00Warning Letter676434
3010203410TJA Health LLCIllinoisUnited StatesDrugs2024-07-17 00:00:00Warning Letter678539
3004142400Globus Medical, Inc.PennsylvaniaUnited StatesDevices2024-07-15 00:00:00Warning Letter685606
3005508657EyePoint Pharmaceuticals, Inc.MassachusettsUnited StatesDrugs2024-07-12 00:00:00Warning Letter679747
3012238587Criticare Technologies, Inc.Rhode IslandUnited StatesDevices2024-07-12 00:00:00Warning Letter686915
3014129013Brassica Pharma Private Ltd-IndiaDrugs2024-07-11 00:00:00Warning Letter679005
3007373503Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)-ChinaDrugs2024-07-11 00:00:00Warning Letter679790
3009721234Nowrez & Ismail Shukri Company-JordanDrugs2024-07-11 00:00:00Warning Letter682810
3004378804Central Admixture Pharmacy Services IncCaliforniaUnited StatesDrugs2024-07-11 00:00:00Warning Letter687936
3030664884Cholrem Pty Ltd-AustraliaDrugs2024-07-09 00:00:00Warning Letter684036
3030694317Cholrem USAUtahUnited StatesDrugs2024-07-09 00:00:00Warning Letter684036
3014321771YangZhou SuXiang Medical Instrument Co., Ltd.-ChinaDrugs2024-07-09 00:00:00Warning Letter686655
3008235829Genuine Virgin Aloe Corp dba TridermaCaliforniaUnited StatesDrugs2024-07-01 00:00:00Warning Letter679744
1000100754Berkeley Biologics LLCCaliforniaUnited StatesBiologics2024-06-28 00:00:00Warning Letter676984
3017517827Baylab USA, LLCTexasUnited StatesDevices2024-06-27 00:00:00Warning Letter679001
3030805935Ozempen.comArizonaUnited StatesDrugs2024-06-27 00:00:00Warning Letter684435
3013693278Rebom Co., Ltd.--Drugs2024-06-26 00:00:00Warning Letter682811
3005906887AMCO International Manufacturing & Design, Inc.New YorkUnited StatesDevices2024-06-25 00:00:00Warning Letter681557
1282959MITMassachusettsUnited StatesBiologics2024-06-21 00:00:00Warning Letter663218
3003320065Laboratorio Magnachem International, S.A.--Drugs2024-06-21 00:00:00Warning Letter673796
3000215345New Mexico Lions Sight Conservation Foundation, Inc.New MexicoUnited StatesBiologics2024-06-21 00:00:00Warning Letter681776
1720129Optikem International, Inc.ColoradoUnited StatesDrugs2024-06-20 00:00:00Warning Letter680264
3002088200Max Chemical IncPuerto RicoUnited StatesDrugs2024-06-20 00:00:00Warning Letter682037
3004561553Sun Pharmaceutical Industries Limited-IndiaDrugs2024-06-18 00:00:00Warning Letter677337
3009562273AG Essence, Inc.VirginiaUnited StatesDevices2024-06-18 00:00:00Warning Letter678344
3005787511Vegewax Candleworx Ltd.-CanadaDrugs2024-06-14 00:00:00Warning Letter675099
3016693877Guangzhou Zuofun Cosmetics Co., Ltd-ChinaDrugs2024-06-13 00:00:00Warning Letter677992
3008384335GFA Production Xiamen Co., Ltd.-ChinaDrugs2024-06-13 00:00:00Warning Letter678364
3010683345Aqualex Co., Ltd.--Drugs2024-06-12 00:00:00Warning Letter672292
3005698871Landy International-ChinaDrugs2024-06-12 00:00:00Warning Letter679066
3002556034ARG Laboratories, Inc.TexasUnited StatesDrugs2024-06-11 00:00:00Warning Letter670899
3010026101Ken Prima Cosmeceuticals, Sdn. Bhd.-MalaysiaDrugs2024-06-10 00:00:00Warning Letter674266
3000718320Indiana Lions Eye Bank, Inc. (dbA VisionFirst Indiana Lions Eye Bank)IndianaUnited StatesBiologics2024-06-10 00:00:00Warning Letter680039
3027391357Angela D. Ritter, M.D.GeorgiaUnited StatesDrugs2024-06-07 00:00:00Warning Letter681999
3017270745TCT NUTRACEUTICALS SDN BHD-MalaysiaDrugs2024-06-06 00:00:00Warning Letter680743
3017371366Neobiosis LLCFloridaUnited StatesBiologics2024-06-05 00:00:00Warning Letter662985
3017151342YAHON ENTERPRISE CO., LTD-VietnamDrugs2024-06-05 00:00:00Warning Letter675592
3015282935FANCYSTAGE, UNIPESSOAL, LDA.-PortugalDrugs2024-06-04 00:00:00Warning Letter678453
3002692859Cosmetic Solutions LLCFloridaUnited StatesDrugs2024-05-31 00:00:00Warning Letter670486
3025922936Konrad Rejdak, M.D.-PolandBiologics2024-05-29 00:00:00Warning Letter671405
3004117460Aruba Aloe Balm N.V.-ArubaDrugs2024-05-13 00:00:00Warning Letter674911
3016758165CUE HEALTH INCCaliforniaUnited StatesDevices2024-05-09 00:00:00Warning Letter675673
3006731547Natuzen Co., Ltd.--Drugs2024-05-03 00:00:00Warning Letter677942
3023815166Kevin R. Bender, M.D.FloridaUnited StatesDrugs2024-05-02 00:00:00Warning Letter680072
3017871874Akan Biosciences IncMarylandUnited StatesBiologics2024-04-30 00:00:00Warning Letter654674
30278883192187954 ALBERTA INC.-CanadaDrugs2024-04-30 00:00:00Warning Letter672166
3012281081Grupo Quimico SRL-UruguayDrugs2024-04-30 00:00:00Warning Letter674010
3013749236Global Cosmetics (China) Company Limited-ChinaDrugs2024-04-30 00:00:00Warning Letter677948
3005668178Washington Fertility CenterVirginiaUnited StatesBiologics2024-04-30 00:00:00Warning Letter678931
3014759234Sani-Care Salon Products, IncGeorgiaUnited StatesDrugs2024-04-24 00:00:00Warning Letter673747
3001236905Cardinal Health 200, LLCIllinoisUnited StatesDevices2024-04-24 00:00:00Warning Letter679404
3005939772Dr. Sankunnis Ayurvedic Research Foundation Pvt Ltd-IndiaDrugs2024-04-18 00:00:00Warning Letter678046
3013828269ZEN ENTERPRISES LLCNevadaUnited StatesDrugs2024-04-18 00:00:00Warning Letter678407
2020372Westwood Laboratories, LLC.CaliforniaUnited StatesDrugs2024-04-17 00:00:00Warning Letter674728
3010982075Pinnacle Labs of Tennessee, LLCTennesseeUnited StatesDevices2024-04-17 00:00:00Warning Letter676367
3005945400Health SpecialtyCaliforniaUnited StatesDrugs2024-04-15 00:00:00Warning Letter675475
3012590153Northern VA Compounders PLLCVirginiaUnited StatesDrugs2024-04-12 00:00:00Warning Letter671700
3012668529C&T Dream Co., Ltd.--Drugs2024-04-11 00:00:00Warning Letter678300
3004540906NATCO Pharma Limited-IndiaDrugs2024-04-09 00:00:00Warning Letter672564
3010970108FirstCham Co., Ltd.--Drugs2024-04-04 00:00:00Warning Letter672903
3017005720Jiangsu Meifan Biotechnology Co., Ltd.-ChinaDrugs2024-04-03 00:00:00Warning Letter676562
3016261803BIOPTIMAL INTERNATIONAL PTE. LTD.-SingaporeDevices2024-04-03 00:00:00Warning Letter678281
3002815949Stokes Healthcare Inc. dba Epicur PharmaNew JerseyUnited StatesDrugs2024-04-02 00:00:00Warning Letter677624
3007709579Seatex LLCTexasUnited StatesDrugs2024-04-01 00:00:00Warning Letter672951
3009590582Central Admixture Pharmacy Services, Inc.PennsylvaniaUnited StatesDrugs2024-03-29 00:00:00Warning Letter674736
3011853060Kilitch Healthcare India Limited-IndiaDrugs2024-03-28 00:00:00Warning Letter672956
3002718545Vintage Chemical, Inc.IndianaUnited StatesDrugs2024-03-27 00:00:00Warning Letter673930
3018011294Bodywell Natural Skin Care Inc.-CanadaDrugs2024-03-27 00:00:00Warning Letter677099
3017200845DERMAL SOURCEOregonUnited StatesDrugs2024-03-25 00:00:00Warning Letter663632
3028005436Painless Tattoo Cream Co.UtahUnited StatesDrugs2024-03-25 00:00:00Warning Letter666693
3015204327INDELICARE DBA INK-EEZECaliforniaUnited StatesDrugs2024-03-25 00:00:00Warning Letter671656
3028008119Mahoney Property Ltd-United KingdomDrugs2024-03-25 00:00:00Warning Letter672467
3027980112TKTX Company-ChinaDrugs2024-03-25 00:00:00Warning Letter673879
3028143571SeeNext Venture LtdWashingtonUnited StatesDrugs2024-03-25 00:00:00Warning Letter674915
3014307835Central Admixture Pharmacy Services, Inc.ArizonaUnited StatesDrugs2024-03-25 00:00:00Warning Letter675065
3025978151Antaria Pty., Ltd.-AustraliaDrugs2024-03-22 00:00:00Warning Letter674495
3010962166Agena Bioscience, Inc.CaliforniaUnited StatesDevices2024-03-21 00:00:00Warning Letter665159
3023259471Bret R. Rutherford, M.D.New YorkUnited StatesDrugs2024-03-21 00:00:00Warning Letter670544
2431841N.Y.S. Psychiatric Institute IRBNew YorkUnited StatesDrugs2024-03-21 00:00:00Warning Letter670989
3005857264Augustine Temperature Management, LLCMinnesotaUnited StatesDevices2024-03-21 00:00:00Warning Letter671243
3016998650Betone, S.A. de C.V.-MexicoDrugs2024-03-21 00:00:00Warning Letter674299
3013042669Deqing Jiarou Daily Chemical Co., Ltd-ChinaDrugs2024-03-19 00:00:00Warning Letter677928
3017370207AMMONIASPORT LLCCaliforniaUnited StatesDrugs2024-03-18 00:00:00Warning Letter672196
3014312726Sol-Millennium Medical Inc.IllinoisUnited StatesDevices2024-03-18 00:00:00Warning Letter677524
1417592MEDLINE INDUSTRIES, LP - NorthfieldIllinoisUnited StatesDevices2024-03-18 00:00:00Warning Letter677545
3003902757Jiangsu Shenli Medical Production Co., Ltd.-ChinaDevices2024-03-18 00:00:00Warning Letter677753
3004369035I.T.S. GmbH-AustriaDevices2024-03-15 00:00:00Warning Letter657885
2122870Beckman Coulter, Inc.MinnesotaUnited StatesDevices2024-03-15 00:00:00Warning Letter678042
3016668136Master Paints & Chemical CorpPuerto RicoUnited StatesDrugs2024-03-13 00:00:00Warning Letter672462
3029879389Skull Smash Ammonia InhalantsMissouriUnited StatesDrugs2024-03-13 00:00:00Warning Letter672714
3023254292SPIROCHAETE RESEARCH LABS LLCNew YorkUnited StatesDrugs2024-03-08 00:00:00Warning Letter674278
3017791225Soulaire CorporationCaliforniaUnited StatesDevices2024-03-06 00:00:00Warning Letter675069
1622491Cosmetic Specialty Labs, IncOklahomaUnited StatesDrugs2024-02-29 00:00:00Warning Letter671239
3014651598NATIVE SALTS LLCIllinoisUnited StatesDrugs2024-02-28 00:00:00Warning Letter674277
3003067499Thai Nakorn Patana Co., Ltd,-ThailandDrugs2024-02-27 00:00:00Warning Letter672712
3002984417Higley Industries, Inc.IowaUnited StatesDrugs2024-02-22 00:00:00Warning Letter669170
3010382813Innovative Formulations LLCArkansasUnited StatesDrugs2024-02-22 00:00:00Warning Letter672952
3027822577LightEyez Limited-United KingdomDrugs2024-02-15 00:00:00Warning Letter665450
3027982030JustChinaItFloridaUnited StatesDrugs2024-02-15 00:00:00Warning Letter665450
3005574978Bell International Laboratories, Inc.MinnesotaUnited StatesDrugs2024-02-15 00:00:00Warning Letter669736
3009529630Philips Healthcare (Suzhou) Co., Ltd.-ChinaDevices2024-02-15 00:00:00Warning Letter676605
3013501887AMMAN PHARMACEUTICAL INDUSTRIES-JordanDrugs2024-02-14 00:00:00Warning Letter668867
3018035065Delsam Pharma LLCNew YorkUnited StatesDrugs2024-02-13 00:00:00Warning Letter657340
3022210898EzriCare, LLC.New JerseyUnited StatesDrugs2024-02-13 00:00:00Warning Letter658390
3017660889Salvacion USA, Inc.New JerseyUnited StatesDrugs2024-02-13 00:00:00Warning Letter672252
3030000849Human MicrobesCaliforniaUnited StatesBiologics2024-02-13 00:00:00Warning Letter672740
3029095356Synthetix Inc. DBA Helix Chemical SupplyNew YorkUnited StatesDrugs2024-02-07 00:00:00Warning Letter668918
3029137335US Chem LabsFloridaUnited StatesDrugs2024-02-07 00:00:00Warning Letter669074
3019951059Ningbo Poplar Daily-Use Commodity Co, Ltd-ChinaDrugs2024-02-06 00:00:00Warning Letter669486
3007588545Global Life Technologies CorporationMarylandUnited StatesDrugs2024-02-06 00:00:00Warning Letter674279
3011139911Sichuan Deebio Pharmaceutical Co., Ltd.-ChinaDrugs2024-02-05 00:00:00Warning Letter669808
3018499361Ehy Holdings LLCNew YorkUnited StatesDrugs2024-02-02 00:00:00Warning Letter675591
3007317099Madhu Instruments Private Limited-IndiaDrugs2024-02-01 00:00:00Warning Letter659694
3006629881Barkey GmbH & Co. KG-GermanyBiologics2024-01-31 00:00:00Warning Letter657073
3003175217Les Importations Herbasante Inc.-CanadaDrugs2024-01-31 00:00:00Warning Letter668412
3005979923S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED-ThailandDrugs2024-01-26 00:00:00Warning Letter668482
3002690289Nobles Medical Technology, IICaliforniaUnited StatesDevices2024-01-26 00:00:00Warning Letter673465
3013931875QuVa Pharma, Inc.New JerseyUnited StatesDrugs2024-01-26 00:00:00Warning Letter675685
1610391Colgin, IncTexasUnited StatesDrugs2024-01-25 00:00:00Warning Letter670332
3012190301Mei Lan (Thailand) Company, Ltd.-ThailandDrugs2024-01-25 00:00:00Warning Letter672783
3015660451Lelypharma BV-NetherlandsDrugs2024-01-24 00:00:00Warning Letter673321
3018095920SAMBROSA CARE INCCaliforniaUnited StatesDrugs2024-01-24 00:00:00Warning Letter673321
1038671Exactech, Inc.FloridaUnited StatesDevices2024-01-19 00:00:00Warning Letter669904
3016420687Glicerinas Industriales, S.A de C.V-MexicoDrugs2024-01-16 00:00:00Warning Letter665472
3001890611Dr. Joel Kaplan Inc.CaliforniaUnited StatesDevices2024-01-08 00:00:00Warning Letter667193
3014732157Fresenius Kabi USA, LLCMassachusettsUnited StatesDevices2024-01-04 00:00:00Warning Letter671249
3017199840Prime Lab LLCPuerto RicoUnited StatesDrugs2024-01-02 00:00:00Warning Letter667057
3014653532Woori Life & Health--Drugs2023-12-28 00:00:00Warning Letter672936
3000134760Techlem Medical Corporation-CanadaDevices2023-12-26 00:00:00Warning Letter671395
3015433660EAST FORK CULTIVARSOregonUnited StatesDrugs2023-12-22 00:00:00Warning Letter654211
3015063793COMERCIALIZADORA HERBAMEX-MexicoDrugs2023-12-21 00:00:00Warning Letter671066
3020861968GRUPO YPENZA DE MEXICO SA DE CV-MexicoDrugs2023-12-21 00:00:00Warning Letter671066
3015859325KUKAMONGA-MexicoDrugs2023-12-21 00:00:00Warning Letter671066
3014611081PLANTAS MEDICINALES DE MEXICO-MexicoDrugs2023-12-21 00:00:00Warning Letter671066
3027716877Botanical BeTexasUnited StatesDrugs2023-12-21 00:00:00Warning Letter671066
3016994737Amazon.com, Inc.WashingtonUnited StatesDrugs2023-12-20 00:00:00Warning Letter662503
3009814715MiMedx Group, Inc.GeorgiaUnited StatesBiologics2023-12-20 00:00:00Warning Letter662942
3027553871Hua Da Trading, Inc. dba Wefun Inc.New YorkUnited StatesDrugs2023-12-20 00:00:00Warning Letter664359
3023464259Jeffrey W. Taub, M.D.MichiganUnited StatesDrugs2023-12-19 00:00:00Warning Letter674545
1000122232Inopak LtdNew JerseyUnited StatesDrugs2023-12-15 00:00:00Warning Letter667411
3009250196Patcos Cosmetics (India) Private Limited-IndiaDrugs2023-12-15 00:00:00Warning Letter669465
3019843904OMEZA LLCFloridaUnited StatesDrugs2023-12-12 00:00:00Warning Letter665762
3023890987Anish Shah, M.D.CaliforniaUnited StatesDrugs2023-12-12 00:00:00Warning Letter674073
3003092372Dextrum Laboratories Inc.FloridaUnited StatesDrugs2023-12-07 00:00:00Warning Letter666442
3028011400Novid Group, IncCaliforniaUnited StatesDrugs2023-12-07 00:00:00Warning Letter672251
2011035COLONIAL DAMES CO LTDCaliforniaUnited StatesDrugs2023-12-06 00:00:00Warning Letter659151
3013324771OXYGENETIX INSTITUTE INCCaliforniaUnited StatesDrugs2023-12-06 00:00:00Warning Letter659151
3001451489Fresenius Medical Care Holdings, Inc.MassachusettsUnited StatesDevices2023-12-04 00:00:00Warning Letter666791
3010496070Sonesta Medical AB-SwedenDevices2023-12-04 00:00:00Warning Letter667325
3029666082Belmont Eyecare LLCIllinoisUnited StatesDrugs2023-12-01 00:00:00Warning Letter670186
3027822578Dr. Berne's Whole Health ProductsNew MexicoUnited StatesDrugs2023-11-22 00:00:00Warning Letter665456
3003157498Intas Pharmaceuticals Limited-IndiaDrugs2023-11-21 00:00:00Warning Letter662868
3008581988Cipla Limited-IndiaDrugs2023-11-17 00:00:00Warning Letter660904
3006057298AmLion Toothpaste Mfg Sdn-MalaysiaDrugs2023-11-17 00:00:00Warning Letter665879
3015509579Nantong Furuida Packaging Products Co., Ltd.-ChinaDrugs2023-11-17 00:00:00Warning Letter667984
3017978054Cerci Kozmetik Ve Otel Ekipmanlari Pazarlama Ic Ve Dis Ticaret Limited Sirketi-TurkeyDrugs2023-11-17 00:00:00Warning Letter669488
3015596082WIPRO CONSUMER CARE VIETNAM CO., LTD-VietnamDrugs2023-11-16 00:00:00Warning Letter660735
3016000795DISCOVER HEALTHColoradoUnited StatesDrugs2023-11-16 00:00:00Warning Letter661488
3009675687Xiamen Wally Bath Manufacture Co., Ltd.-ChinaDrugs2023-11-15 00:00:00Warning Letter669407
3005672908Amazon.comKentuckyUnited StatesDrugs2023-11-13 00:00:00Warning Letter665460
3016994737Amazon.com, Inc.WashingtonUnited StatesDrugs2023-11-13 00:00:00Warning Letter665460
3004647124SUDESAN TEMIZLIK URUNLERI VE AMBALAJ SANAYI TICARET ANONIM S-TurkeyDrugs2023-11-13 00:00:00Warning Letter666900
3011214569Wello, Inc.TexasUnited StatesDevices2023-11-10 00:00:00Warning Letter664806
1000071237National Chemical LaboratoriesPennsylvaniaUnited StatesDrugs2023-11-08 00:00:00Warning Letter662110
3023878838Melanie M Hoppers, MDTennesseeUnited StatesDrugs2023-11-08 00:00:00Warning Letter671684
3018310083Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi-TurkeyDrugs2023-11-06 00:00:00Warning Letter669487
3013145340TERRAGENE S.A.-ArgentinaDevices2023-11-01 00:00:00Warning Letter667432
3005086865Acrostak (Schweiz) AG-SwitzerlandDevices2023-10-31 00:00:00Warning Letter668948
2126821Brenntag Great Lakes, LLCWisconsinUnited StatesDrugs2023-10-27 00:00:00Warning Letter660268
3008069988Neurotris, Inc. dba A1 EngineeringCaliforniaUnited StatesDevices2023-10-26 00:00:00Warning Letter659244
1415939Abbott LaboratoriesIllinoisUnited StatesBiologics2023-10-24 00:00:00Warning Letter669353
1513768Abbott LaboratoriesOhioUnited StatesBiologics2023-10-24 00:00:00Warning Letter669353
3012013973Elemental Herbs, Inc.CaliforniaUnited StatesDrugs2023-10-20 00:00:00Warning Letter654879
3013757456WAVi Co.ColoradoUnited StatesDevices2023-10-20 00:00:00Warning Letter658549
3006252706Samm Solutions, Inc (dba) BTS ResearchCaliforniaUnited StatesDrugs2023-10-20 00:00:00Warning Letter663898
3002960047Maria W. Greenwald, MDCaliforniaUnited StatesDrugs2023-10-20 00:00:00Warning Letter670580
3012323885Global Pharma Healthcare Private Limited-IndiaDrugs2023-10-19 00:00:00Warning Letter657325
3014023545ReNovo, Inc.OregonUnited StatesDevices2023-10-13 00:00:00Warning Letter664014
3007295883Handock Cosmetics Co., Ltd.--Drugs2023-10-04 00:00:00Warning Letter658737
3007253462Seoul Cosmetics Co., Ltd.--Drugs2023-10-02 00:00:00Warning Letter653882
3002807701Neitz Instruments Co., Ltd.-JapanDevices2023-10-02 00:00:00Warning Letter664336
3006073153Spectrum Medical Ltd.-United KingdomDevices2023-09-29 00:00:00Warning Letter666543
3012767995Infinant Health, LLCCaliforniaUnited StatesBiologics2023-09-28 00:00:00Warning Letter667715
3015928879Antonio E. Blanco, M.D.FloridaUnited StatesDrugs2023-09-26 00:00:00Warning Letter668519
3027955125Shot of Joy LLCCaliforniaUnited StatesDrugs2023-09-25 00:00:00Warning Letter665936
3009545790Byd Precision Manufacture Co., Ltd-ChinaDevices2023-09-21 00:00:00Warning Letter666250
3004858203Pharmacy InnovationsPennsylvaniaUnited StatesDrugs2023-09-20 00:00:00Warning Letter667414
3024611819Luis Pena-Hernandez, M.D.FloridaUnited StatesDrugs2023-09-20 00:00:00Warning Letter668217
1220648Abiomed, Inc.MassachusettsUnited StatesDevices2023-09-19 00:00:00Warning Letter663150
3001576493P.T. Sankei Medical Industries-IndonesiaDevices2023-09-19 00:00:00Warning Letter665754
3017242852Hygienic Labs, LLC.IowaUnited StatesDrugs2023-09-19 00:00:00Warning Letter667816
3018035114Signature Biologics, LLCTexasUnited StatesBiologics2023-09-18 00:00:00Warning Letter631039
3014354419ZHAO QING LONGDA BIOTECHNOLOGY CO.,LTD-ChinaDrugs2023-09-18 00:00:00Warning Letter664934
3011761882Curexa - East, LLC dba CurexaNew JerseyUnited StatesDrugs2023-09-15 00:00:00Warning Letter663403
2627511Fenwal International, Inc.Puerto RicoUnited StatesBiologics2023-09-14 00:00:00Warning Letter657085
3017125078Maison Blanche LLCTexasUnited StatesDrugs2023-09-14 00:00:00Warning Letter666943
1460851Walgreen CompanyIllinoisUnited StatesDrugs2023-09-12 00:00:00Warning Letter662158
3007520648Gulf States International IncAlabamaUnited StatesDrugs2023-09-12 00:00:00Warning Letter666918
1000110034Similasan AG-SwitzerlandDrugs2023-09-11 00:00:00Warning Letter658878
3000204701Kor- Chem IncGeorgiaUnited StatesDrugs2023-09-11 00:00:00Warning Letter661280
3013501887AMMAN PHARMACEUTICAL INDUSTRIES-JordanDrugs2023-09-11 00:00:00Warning Letter663037
1720129Optikem International, Inc.ColoradoUnited StatesDrugs2023-09-11 00:00:00Warning Letter663037
3009705561Sterling Pharmaceutical Services LLCIllinoisUnited StatesDrugs2023-09-11 00:00:00Warning Letter663037
3005608157TRP CompanyNevadaUnited StatesDrugs2023-09-11 00:00:00Warning Letter663037
3027582427DR Vitamins, LLCTexasUnited StatesDrugs2023-09-11 00:00:00Warning Letter663127
1217081CVS HealthRhode IslandUnited StatesDrugs2023-09-11 00:00:00Warning Letter663246
3004351878Boiron-FranceDrugs2023-09-11 00:00:00Warning Letter663402
3004611192Boiron-FranceDrugs2023-09-11 00:00:00Warning Letter663402
2510831Boiron Inc.PennsylvaniaUnited StatesDrugs2023-09-11 00:00:00Warning Letter663402
1460851Walgreen CompanyIllinoisUnited StatesDrugs2023-09-11 00:00:00Warning Letter663404
3027605575OcluMedPennsylvaniaUnited StatesDrugs2023-09-11 00:00:00Warning Letter663525
3010171880Natural OphthalmicsColoradoUnited StatesDrugs2023-09-11 00:00:00Warning Letter663758
3004518552Natural Ophthalmics, Inc.ColoradoUnited StatesDrugs2023-09-11 00:00:00Warning Letter663758
3003315146Caltag Medsystems Ltd-United KingdomDevices2023-09-07 00:00:00Warning Letter662115
1218914Safecor Health, LLCMassachusettsUnited StatesDrugs2023-09-05 00:00:00Warning Letter657886
3011069063Kimera Labs IncFloridaUnited StatesBiologics2023-09-01 00:00:00Warning Letter649343
3019411371Purechempros LLCArizonaUnited StatesDrugs2023-09-01 00:00:00Warning Letter649677
3013338037Green Pharmaceutical Co., Ltd.--Drugs2023-08-23 00:00:00Warning Letter663544
3015387681MOLLUSCUMRXFloridaUnited StatesDrugs2023-08-18 00:00:00Warning Letter648457
3007963810Nature's Innovation, Inc.GeorgiaUnited StatesDrugs2023-08-18 00:00:00Warning Letter648560
3014706754Walmart Fulfillment KY1 9074KentuckyUnited StatesDrugs2023-08-18 00:00:00Warning Letter648620
3005672908Amazon.comKentuckyUnited StatesDrugs2023-08-18 00:00:00Warning Letter649056
3016994737Amazon.com, Inc.WashingtonUnited StatesDrugs2023-08-18 00:00:00Warning Letter649056
3025765197Thrasio LLCMassachusettsUnited StatesDrugs2023-08-18 00:00:00Warning Letter649788
3025796097Molluscum AwayFloridaUnited StatesDrugs2023-08-18 00:00:00Warning Letter650100
1031041Lex, Inc.FloridaUnited StatesDrugs2023-08-17 00:00:00Warning Letter656056
1121788Ambu Inc.MarylandUnited StatesDevices2023-08-16 00:00:00Warning Letter661617
1824226King Systems Corp. dba Ambu, Inc.IndianaUnited StatesDevices2023-08-16 00:00:00Warning Letter661617
3008611487Gadal Laboratories Inc.FloridaUnited StatesDrugs2023-08-15 00:00:00Warning Letter655929
3016756938K.Boeun Pharmaceutical Co.,Ltd.--Drugs2023-08-14 00:00:00Warning Letter665099
3003921470COSMOBEAUTI LABORATORIES & MANUFACTURING, INC.CaliforniaUnited StatesDrugs2023-08-11 00:00:00Warning Letter657682
3023229437Tesla Biohealing, Inc.DelawareUnited StatesDevices2023-08-10 00:00:00Warning Letter658010
3020678722CALMCO LLCFloridaUnited StatesDrugs2023-08-09 00:00:00Warning Letter663668
1413064Alva-Amco Pharmacal Cos Inc.IllinoisUnited StatesDrugs2023-08-09 00:00:00Warning Letter663727
3006403166International Laboratories Corp-ThailandDrugs2023-08-08 00:00:00Warning Letter664352
3022938366Angela M. Stupi, M.D.PennsylvaniaUnited StatesDrugs2023-08-08 00:00:00Warning Letter665471
3017301021Laavo Clean, S.A. de C.V.-MexicoDrugs2023-08-07 00:00:00Warning Letter646574
3017539604CERGOMEX IMPORTS LLCTexasUnited StatesDrugs2023-08-04 00:00:00Warning Letter664362
3012495223GTP International CorpTexasUnited StatesDrugs2023-08-04 00:00:00Warning Letter664367
2518137AstraZeneca Pharmaceuticals LPDelawareUnited StatesDrugs2023-08-04 00:00:00Warning Letter664789
2026940K.C. Pharmaceuticals, IncCaliforniaUnited StatesDrugs2023-08-03 00:00:00Warning Letter654986
3007255059LCC Ltd.--Drugs2023-08-03 00:00:00Warning Letter657336
3015282935FANCYSTAGE, UNIPESSOAL, LDA.-PortugalDrugs2023-08-03 00:00:00Warning Letter657341
3004135088Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S.-TurkeyDrugs2023-08-03 00:00:00Warning Letter659854
3015154915ORCHID LIFESCIENCES-IndiaDrugs2023-08-03 00:00:00Warning Letter663478
3016067439Suhan Aerosol-IndiaDrugs2023-08-03 00:00:00Warning Letter663489
3012845410Sangleaf Pharm., Co Ltd--Drugs2023-08-03 00:00:00Warning Letter663495
3014583374Avaria Health & Beauty Corp.-CanadaDrugs2023-08-03 00:00:00Warning Letter663507
3010164172KM PHARMACEUTICAL CO., LTD.--Drugs2023-08-03 00:00:00Warning Letter663522
3006127560Daxal Cosmetics Pvt. Ltd.-IndiaDrugs2023-08-03 00:00:00Warning Letter663658
3017104669Skyline Herbals Private Limited-IndiaDrugs2023-08-03 00:00:00Warning Letter663659
3004011473Intas Pharmaceuticals Limited-IndiaDrugs2023-07-28 00:00:00Warning Letter652067
1210580Denison Pharmaceuticals, LLCRhode IslandUnited StatesDrugs2023-07-26 00:00:00Warning Letter654226
3010680515US Specialty Formulations LLCPennsylvaniaUnited StatesDrugs2023-07-26 00:00:00Warning Letter659142
3008861619Centaur Pharmaceuticals Private Ltd.-IndiaDrugs2023-07-25 00:00:00Warning Letter655231
1626310Iso-Tex Diagnostics, Inc.TexasUnited StatesDrugs2023-07-21 00:00:00Warning Letter655666
3012263900Gadget Island, IncCaliforniaUnited StatesDrugs2023-07-21 00:00:00Warning Letter658733
3010165392MEDGEL PRIVATE LIMITED-IndiaDrugs2023-07-20 00:00:00Warning Letter654085
3027306194Wise Women's ChoiceTexasUnited StatesDrugs2023-07-20 00:00:00Warning Letter658897
3007090726Avlon Industries, IncIllinoisUnited StatesDrugs2023-07-18 00:00:00Warning Letter652903
3010744574LXR BiotechMichiganUnited StatesDrugs2023-07-17 00:00:00Warning Letter652756
3004170064TEI Biosciences, Inc.MassachusettsUnited StatesDevices2023-07-17 00:00:00Warning Letter660960
2211383Jamol Laboratories, Inc.New JerseyUnited StatesDrugs2023-07-13 00:00:00Warning Letter654464
3010355846Outset Medical, Inc.CaliforniaUnited StatesDevices2023-07-05 00:00:00Warning Letter656485
3027398816Sunshine Trading Company, IncColoradoUnited StatesDrugs2023-07-03 00:00:00Warning Letter660633
1922337Fuller Industries, IncKansasUnited StatesDrugs2023-06-29 00:00:00Warning Letter654425
1049818Edge Biologicals IncTennesseeUnited StatesDevices2023-06-27 00:00:00Warning Letter660003
3004731564Colorado Center for Reproductive Medicine, LCVirginiaUnited StatesBiologics2023-06-26 00:00:00Warning Letter658251
3015301033Lydia Co Ltd.--Drugs2023-06-26 00:00:00Warning Letter659646
3017531807LABORATORIOS DE FUERZA DE LA SALUD S.A DE CV-MexicoDrugs2023-06-22 00:00:00Warning Letter657631
3025764224Suprimo ImportsCaliforniaUnited StatesDrugs2023-06-22 00:00:00Warning Letter657631
3016750083Row1 Inc. dba Regenative LabsFloridaUnited StatesBiologics2023-06-21 00:00:00Warning Letter638823
3008493238ZYTO Technologies, Inc.UtahUnited StatesDevices2023-06-21 00:00:00Warning Letter652316
3011585599Glenmark Pharmaceuticals Inc USANorth CarolinaUnited StatesDrugs2023-06-20 00:00:00Warning Letter637162
3014675751Chengdu KeCheng Fine Chemicals Co., Ltd.-ChinaDrugs2023-06-20 00:00:00Warning Letter659389
3002686308Randy J. Epstein, M.D.IllinoisUnited StatesDrugs2023-06-14 00:00:00Warning Letter658917
3015549533VITANG TECHNOLOGY LLCCaliforniaUnited StatesDevices2023-06-12 00:00:00Warning Letter653455
3026850357Warrior Labz SARMsCaliforniaUnited StatesDrugs2023-06-12 00:00:00Warning Letter655280
3014171113Stratus BioSystems, LLCTexasUnited StatesBiologics2023-06-09 00:00:00Warning Letter631303
3015826782Carolina InfusionSouth CarolinaUnited StatesDrugs2023-06-09 00:00:00Warning Letter659408
3009729473Safe Chain Solutions, LlcMarylandUnited StatesDrugs2023-06-08 00:00:00Warning Letter636044
3010241801Vital Care Compounder, IncMississippiUnited StatesDrugs2023-06-06 00:00:00Warning Letter659051
3003973520Centaur Pharmaceuticals Private Ltd.-IndiaDrugs2023-06-05 00:00:00Warning Letter651080
3021858471RMLC Industries LLC dba Mr. Lulu LLCCaliforniaUnited StatesDrugs2023-06-01 00:00:00Warning Letter650772
3019300800RenatiLabs IncKentuckyUnited StatesBiologics2023-05-31 00:00:00Warning Letter646353
3003340745Ming Fai Industrial (Shenzhen) Co LTD-ChinaDevices2023-05-31 00:00:00Warning Letter660075
3021539793Mobeen Mazhar, M.D.TexasUnited StatesDrugs2023-05-31 00:00:00Warning Letter660335
3002998723Neilmed Pharmaceuticals IncCaliforniaUnited StatesDrugs2023-05-26 00:00:00Warning Letter650263
3003348498ImprimisRx NJNew JerseyUnited StatesDrugs2023-05-26 00:00:00Warning Letter657453
3021769057iRhythm Technologies, Inc.CaliforniaUnited StatesDevices2023-05-25 00:00:00Warning Letter643474
3005138409Steiner Biotechnology LLCNevadaUnited StatesDevices2023-05-19 00:00:00Warning Letter651802
3018725547CMHP Private Limited-IndiaDrugs2023-05-18 00:00:00Warning Letter656743
3012282535CAD Import Inc.DelawareUnited StatesDrugs2023-05-18 00:00:00Warning Letter656743
3008874708Pharmadel, LLCDelawareUnited StatesDrugs2023-05-18 00:00:00Warning Letter656743
3010371376New England Life Care, Inc. dba Advanced Compounding SolutionsMassachusettsUnited StatesDrugs2023-05-16 00:00:00Warning Letter659161
3005841768RemedyRepack Inc.PennsylvaniaUnited StatesDrugs2023-05-11 00:00:00Warning Letter649198
3025370979iSlim LLCFloridaUnited StatesDrugs2023-05-04 00:00:00Warning Letter655819
3016775373Drivergent, Inc.MichiganUnited StatesDrugs2023-05-01 00:00:00Warning Letter647234
3015269827Pharmedica USA, LLCArizonaUnited StatesDrugs2023-04-28 00:00:00Warning Letter648269
3025403089Tager Online, Inc. DBA Volt Candy; Volt Candy Wholesale ClubCaliforniaUnited StatesDrugs2023-04-27 00:00:00Warning Letter652780
3012559261voltcandyonline.comCaliforniaUnited StatesDrugs2023-04-27 00:00:00Warning Letter652780
3025627251Nose Slap, LLCIdahoUnited StatesDrugs2023-04-24 00:00:00Warning Letter654566
3026975400Sorcerz.comTexasUnited StatesDrugs2023-04-21 00:00:00Warning Letter656021
1818911Accra-Pac, Inc.IndianaUnited StatesDrugs2023-04-20 00:00:00Warning Letter643600
3016851361MEDOLIFE CORPCaliforniaUnited StatesDrugs2023-04-19 00:00:00Warning Letter651522
3006640241Medolife CorpCaliforniaUnited StatesDrugs2023-04-19 00:00:00Warning Letter651522
3015989830QUANTA INCCaliforniaUnited StatesDrugs2023-04-19 00:00:00Warning Letter651522
3016926047QUANTA INC.CaliforniaUnited StatesDrugs2023-04-19 00:00:00Warning Letter651522
3003767891Pharmaplast S.A.E.-EgyptDrugs2023-04-13 00:00:00Warning Letter648883
3018725547CMHP Private Limited-IndiaDrugs2023-04-10 00:00:00Warning Letter652319
3003659249Zermat Internacional, S.A. de C.V.-MexicoDrugs2023-04-06 00:00:00Warning Letter647232
2517008Royal Chemical CompanyPennsylvaniaUnited StatesDrugs2023-04-05 00:00:00Warning Letter648378
1037230Sea-Long Medical Systems, LLCTexasUnited StatesDevices2023-04-04 00:00:00Warning Letter647320
3010621916Drug Depot, LLC., dba APS PharmacyFloridaUnited StatesDrugs2023-03-31 00:00:00Warning Letter653740
1920841ALI Pharmaceutical Manufacturing LLCNebraskaUnited StatesDrugs2023-03-30 00:00:00Warning Letter645781
3023533273Sure-Biochem Laboratories, LLCNew JerseyUnited StatesDrugs2023-03-24 00:00:00Warning Letter646619
2280596Synovo ProductionCaliforniaUnited StatesDevices2023-03-23 00:00:00Warning Letter647427
3020491814Tyrone McCall, M.D.TexasUnited StatesDrugs2023-03-22 00:00:00Warning Letter651261
2246857Omega Packaging CorpNew JerseyUnited StatesDrugs2023-03-20 00:00:00Warning Letter649122
3003637092Olympus Medical Systems Corp.-JapanDevices2023-03-15 00:00:00Warning Letter654013
3002744909Procter & Gamble Manufactura S. de R.L. de C.V.-MexicoDrugs2023-03-14 00:00:00Warning Letter650837
3022205731Robert Hayashi M.DMissouriUnited StatesDrugs2023-03-14 00:00:00Warning Letter654873
3004943112NuGeneration Technologies, LLCCaliforniaUnited StatesDrugs2023-03-13 00:00:00Warning Letter645821
3001697625Cosmetic Science Laboratories, LLCCaliforniaUnited StatesDrugs2023-03-10 00:00:00Warning Letter645558
3017155458Maggie Jeffries MDTexasUnited StatesDrugs2023-03-03 00:00:00Warning Letter646498
3014278936Formology Lab Inc.CaliforniaUnited StatesDrugs2023-03-01 00:00:00Warning Letter644745
3001238690Massco DentalArkansasUnited StatesDrugs2023-02-23 00:00:00Warning Letter644335
3010222586Gasco Industrial Corp.Puerto RicoUnited StatesDrugs2023-02-17 00:00:00Warning Letter647393
3003945152Frenda CorporationPuerto RicoUnited StatesDrugs2023-02-15 00:00:00Warning Letter642267
3001236208Midlab IncorporatedTennesseeUnited StatesDrugs2023-02-15 00:00:00Warning Letter642374
3010166780Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil-TurkeyDrugs2023-02-13 00:00:00Warning Letter645478
3003982003Medivance Instruments Ltd.-United KingdomDevices2023-02-13 00:00:00Warning Letter647562
3025764508The Body Bean LLCCaliforniaUnited StatesDrugs2023-02-06 00:00:00Warning Letter649817
3010837197Fischer ANalysen Instrumente GmbH-GermanyDevices2023-02-03 00:00:00Warning Letter650388
3011873350Profounda IncFloridaUnited StatesDrugs2023-02-01 00:00:00Warning Letter642595
3015237167Clean Cosmetics, LLCCaliforniaUnited StatesDrugs2023-02-01 00:00:00Warning Letter643205
3012048333LGM Pharma LLCKentuckyUnited StatesDrugs2023-01-30 00:00:00Injunction379
3003892002Fei Fah Medical Manufacturing Pte. Ltd.-SingaporeDrugs2023-01-30 00:00:00Warning Letter633084
3024359859Old Tiles DecorUtahUnited StatesDrugs2023-01-30 00:00:00Warning Letter643920
3024549627Old Tiles Wallpaper, LLC DBA Old Tiles DecorUtahUnited StatesDrugs2023-01-30 00:00:00Warning Letter643920
3024549692Monkeypox-treatment.com-NetherlandsDrugs2023-01-30 00:00:00Warning Letter644773
3003079019Kobayashi America Manufacturing, LLCGeorgiaUnited StatesDrugs2023-01-27 00:00:00Warning Letter637313
3020256087Skyless LLCPuerto RicoUnited StatesDrugs2023-01-23 00:00:00Warning Letter636200
3014117482Atlantic Management Resources Ltd.MassachusettsUnited StatesDrugs2023-01-20 00:00:00Warning Letter642082
3010096700B & J GroupPennsylvaniaUnited StatesDrugs2023-01-19 00:00:00Warning Letter641099
1610021Mohawk Laboratories Division of NCH Corp.TexasUnited StatesDrugs2023-01-18 00:00:00Warning Letter635780
3012197003Buzzagogo, LLCNew HampshireUnited StatesDrugs2023-01-18 00:00:00Warning Letter639545
1000113240Larkin Community Hospital IRBFloridaUnited StatesDrugs2023-01-11 00:00:00Warning Letter638146
3022538886Adam's SecretNew YorkUnited StatesDrugs2023-01-10 00:00:00Warning Letter646494
3017684142AdamsSecret.comNew JerseyUnited StatesDrugs2023-01-10 00:00:00Warning Letter646494
3018082081AS Global INCNew YorkUnited StatesDrugs2023-01-10 00:00:00Warning Letter646494
3017128399HIS ENTERPRISE INCNew JerseyUnited StatesDrugs2023-01-10 00:00:00Warning Letter646494
3005585787His SalesNew YorkUnited StatesDrugs2023-01-10 00:00:00Warning Letter646494
3018094463Miss SlimNew JerseyUnited StatesDrugs2023-01-10 00:00:00Warning Letter646494
3025180991Medical Mikes, Inc.New YorkUnited StatesDrugs2023-01-10 00:00:00Warning Letter647603
3011328724Purecraft LlcCaliforniaUnited StatesDrugs2023-01-10 00:00:00Warning Letter648077
3014001652Kunming Aolym Biotech Co.,Ltd-ChinaDrugs2023-01-09 00:00:00Warning Letter643724
3013972005Distributor RFR, LLC.FloridaUnited StatesDrugs2023-01-09 00:00:00Warning Letter643724
3025183167PharmaCannaFloridaUnited StatesDrugs2023-01-05 00:00:00Warning Letter647390
3008185830Hoya Corporation - Pentax Life Division-JapanDevices2023-01-01 00:00:00Warning Letter461447
3009482034Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.-TurkeyDevices2022-12-29 00:00:00Warning Letter649158
3017057656Reflow Supply Chain Solutions LLCTexasUnited StatesDrugs2022-12-27 00:00:00Warning Letter635791
3016759092Urban Electric PowerNew YorkUnited StatesDrugs2022-12-27 00:00:00Warning Letter635791
3021477751North American DiagnosticsFloridaUnited StatesDevices2022-12-27 00:00:00Warning Letter643203
3008911114GETSCH+HILLER MEDIZINTECHNIK GmbH-GermanyDevices2022-12-27 00:00:00Warning Letter644680
3011185319Salon Technologies International IncFloridaUnited StatesDrugs2022-12-21 00:00:00Warning Letter630566
3011622931Ultra Chem Labs CorpCaliforniaUnited StatesDrugs2022-12-21 00:00:00Warning Letter641742
3010164603Auto-Chlor System LLCGeorgiaUnited StatesDrugs2022-12-20 00:00:00Warning Letter641808
3015176873RIGHTEYE, LLCMarylandUnited StatesDevices2022-12-20 00:00:00Warning Letter643192
3004079658Green Pharmaceuticals, Inc.CaliforniaUnited StatesDrugs2022-12-16 00:00:00Warning Letter635162
3006217765SUPERIOR GLOVE WORKS, LTD.-CanadaDrugs2022-12-16 00:00:00Warning Letter641100
3017716431Adarsh Daswani, M.D.CaliforniaUnited StatesDrugs2022-12-14 00:00:00Warning Letter648606
3017600845Optum Infusion Services 308, LLCArizonaUnited StatesDrugs2022-12-13 00:00:00Warning Letter647842
3002807795Olympus Medical Systems Corporation-JapanDevices2022-12-12 00:00:00Warning Letter649726
3017303868PREMIER NUTRA PHARMA Inc.CaliforniaUnited StatesDrugs2022-12-09 00:00:00Warning Letter640210
3007616930Nortec Quimica SA-BrazilDrugs2022-12-08 00:00:00Warning Letter639894
3004497364Centrient Pharmaceuticals India Private Limited-IndiaDrugs2022-12-07 00:00:00Warning Letter640196
3030709779Thriftmaster Global Holdings, Inc.TexasUnited StatesDrugs2022-12-05 00:00:00Warning Letter641057
3013947845DuPont Nutrition USA, IncDelawareUnited StatesDrugs2022-12-02 00:00:00Warning Letter627211
3015320016Kari Gran Inc.WashingtonUnited StatesDrugs2022-11-30 00:00:00Warning Letter640035
3002892007AG Hair Ltd.-CanadaDrugs2022-11-28 00:00:00Warning Letter638646
3012369470MD Pharmaceutical Supply, LLCPennsylvaniaUnited StatesDrugs2022-11-23 00:00:00Warning Letter637815
3003159106Aspire Pharmaceuticals, Inc.New JerseyUnited StatesDrugs2022-11-22 00:00:00Warning Letter630105
3004672766Glenmark Pharmaceuticals Limited-IndiaDrugs2022-11-22 00:00:00Warning Letter637314
3022074304RoyalVibe Health Ltd.TexasUnited StatesDevices2022-11-18 00:00:00Warning Letter639553
3014229024North American Custom Laboratories, LLC dba FarmaKeio Superior Custom CompoundingTexasUnited StatesDrugs2022-11-18 00:00:00Warning Letter642792
3015595236David M. Lubeck MDIllinoisUnited StatesDrugs2022-11-18 00:00:00Warning Letter643531
3004450713Denker, Mark S, MD PAFloridaUnited StatesBiologics2022-11-17 00:00:00Warning Letter643090
3017492969Wintech Medipro LLCTexasUnited StatesDevices2022-11-16 00:00:00Warning Letter640048
3002900199Cutera, Inc.CaliforniaUnited StatesDevices2022-11-10 00:00:00Warning Letter639552
3015252551Invitrx Therapeutics Inc.CaliforniaUnited StatesBiologics2022-11-09 00:00:00Warning Letter630712
3005643513Abbott Point of Care Canada Limited-CanadaDevices2022-11-08 00:00:00Warning Letter640946
3016861323ANTHOS GROUP, INC, THECaliforniaUnited StatesDrugs2022-11-04 00:00:00Warning Letter636846
2650091Omega & Delta Co., Inc.Puerto RicoUnited StatesDrugs2022-11-02 00:00:00Warning Letter636606
3002964398Aizu Olympus Co., Ltd.-JapanDevices2022-11-02 00:00:00Warning Letter643172
3023804081CannaAidNorth CarolinaUnited StatesDrugs2022-11-01 00:00:00Warning Letter641241
3006441852Abraxis Bioscience, LLCArizonaUnited StatesDrugs2022-10-31 00:00:00Warning Letter633713
3005672908Amazon.comKentuckyUnited StatesDrugs2022-10-28 00:00:00Warning Letter631751
3016994737Amazon.com, Inc.WashingtonUnited StatesDrugs2022-10-28 00:00:00Warning Letter631751
3021982187Latin Foods MarketCaliforniaUnited StatesDrugs2022-10-28 00:00:00Warning Letter631753
3014706754Walmart Fulfillment KY1 9074KentuckyUnited StatesDrugs2022-10-28 00:00:00Warning Letter631755
3011402904Cryos International USA, LLCFloridaUnited StatesBiologics2022-10-24 00:00:00Warning Letter639696
3024142962Lakpura LLCDelawareUnited StatesDrugs2022-10-24 00:00:00Warning Letter643057
3011158388Nephron Sterile Compounding Center LLCSouth CarolinaUnited StatesDrugs2022-10-21 00:00:00Warning Letter644180
3024210457Rite Aid CorporationPennsylvaniaUnited StatesDrugs2022-10-19 00:00:00Warning Letter643207
3010298400Mcconnell Labs IncOregonUnited StatesDrugs2022-10-18 00:00:00Warning Letter638958
3010164341Unit Dose Services, LLCFloridaUnited StatesDrugs2022-10-17 00:00:00Warning Letter636177
3010892830Nephron Sc IncSouth CarolinaUnited StatesDrugs2022-10-11 00:00:00Warning Letter634647
3017977164Empowered Diagnostics LLCFloridaUnited StatesDevices2022-10-07 00:00:00Warning Letter638164
3017227582Beijing Xinggu Lvsan Technology Co., Ltd-ChinaDrugs2022-10-05 00:00:00Warning Letter633904
3003229412Sovereign Pharmaceuticals, LLCTexasUnited StatesDrugs2022-10-05 00:00:00Warning Letter634233
3016927597Eksa Mills S.A. de C.V.-MexicoDrugs2022-10-05 00:00:00Warning Letter634706
3004453700Legacy Pharmaceutical Packaging LLCMissouriUnited StatesDrugs2022-10-03 00:00:00Warning Letter633735
3010079067MicroVention Costa Rica S.R.L.-Costa RicaDevices2022-09-30 00:00:00Warning Letter643188
3003059934Advanced Cosmetic Research Laboratories, Inc.CaliforniaUnited StatesDrugs2022-09-28 00:00:00Warning Letter635176
3014847263Bespoke Apothecary Limited Liability CorporationNew YorkUnited StatesDrugs2022-09-28 00:00:00Warning Letter641573
3009705561Sterling Pharmaceutical Services LLCIllinoisUnited StatesDrugs2022-09-27 00:00:00Warning Letter629019
3002807512Lupin Limited-IndiaDrugs2022-09-27 00:00:00Warning Letter633703
3013934051Forcemech International LLCTexasUnited StatesDevices2022-09-21 00:00:00Warning Letter634891
3004966182Eco Lips, Inc.IowaUnited StatesDrugs2022-09-20 00:00:00Warning Letter631629
3011408975System Kosmetik Produktionsgesellschaft fur kosmetische Gmbh-GermanyDrugs2022-09-20 00:00:00Warning Letter632727
3015602723Med Pen Concepts, LLCMassachusettsUnited StatesDevices2022-09-15 00:00:00Warning Letter632974
3001587133American Cleaning SolutionsNew YorkUnited StatesDrugs2022-09-06 00:00:00Warning Letter632881
3017183921Sanitizer Supply LLCGeorgiaUnited StatesDrugs2022-09-02 00:00:00Warning Letter633583
3021718051AMS Packaging IncNew JerseyUnited StatesDrugs2022-09-01 00:00:00Warning Letter630110
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3017529301Dermacare Packaging & Private Label LLCFloridaUnited StatesDevices2021-12-01 00:00:00Warning Letter617910
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3013332813NUTROVAPE LLCFloridaUnited StatesDrugs2021-12-01 00:00:00Warning Letter617979
1413475Dental Technologies Inc.IllinoisUnited StatesDrugs2021-11-30 00:00:00Warning Letter612599
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3014171792INDUCTION THERAPIES LLCKentuckyUnited StatesDevices2021-11-23 00:00:00Warning Letter616487
3010580682Hubei Kangzheng Pharmaceutical Co., Ltd.-ChinaDrugs2021-11-23 00:00:00Warning Letter616581
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3017231855BIONATEO SP ZOO-PolandDrugs2021-11-04 00:00:00Warning Letter614651
3013677509DongBang Cosmetics Co., Ltd.--Drugs2021-10-22 00:00:00Warning Letter610364
3007594734CellEra LLCOhioUnited StatesDevices2021-10-20 00:00:00Warning Letter618209
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3012644697Ardil Comercial S.R.L.--Drugs2021-09-22 00:00:00Warning Letter612018
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3018675348Vivera Pharmaceuticals Inc.CaliforniaUnited StatesDevices2021-07-26 00:00:00Warning Letter614382
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3017132984OPGAL OPTRONIC INDUSTRIES LTD-IsraelDevices2021-03-04 00:00:00Warning Letter613562
3017179586SHENZHEN SUNELL TECHNOLOGY CORPORATION-ChinaDevices2021-03-04 00:00:00Warning Letter613563
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3009028295Thermoteknix System Limited-United KingdomDevices2021-03-04 00:00:00Warning Letter613565
3016736153WESTMINSTER INTERNATIONAL-United KingdomDevices2021-03-04 00:00:00Warning Letter613566
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3016680234YARA ELENA DE LA GARZA PEREZ NIETO-MexicoDrugs2021-02-22 00:00:00Warning Letter608697
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3016840170Fair Price Labs, Inc.TennesseeUnited StatesDevices2020-07-24 00:00:00Warning Letter607832
3016851462Diagnostic Solutions Laboratory, LLCGeorgiaUnited StatesDevices2020-07-24 00:00:00Warning Letter607885
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3013537103COREMEDICA LABORATORIES LLCMissouriUnited StatesDevices2020-07-24 00:00:00Warning Letter608757
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3015134033ACRX Specialty Pharmacy IncNevadaUnited StatesDrugs2020-07-24 00:00:00Warning Letter609518
1250045The Tender CorporationNew HampshireUnited StatesDrugs2020-07-23 00:00:00Warning Letter599789
3016678056Eskbiochem SA de CV-MexicoDrugs2020-07-23 00:00:00Warning Letter608690
301679050921st Century LaserMed Pain InstituteCaliforniaUnited StatesBiologics2020-07-21 00:00:00Warning Letter607654
3016816960Pharmaboosters.com-RussiaDrugs2020-07-15 00:00:00Warning Letter607929
3002808161Signa S.A. de C.V.-MexicoDrugs2020-07-14 00:00:00Warning Letter605219
3013559620Eosera, Inc.TexasUnited StatesDrugs2020-07-13 00:00:00Warning Letter605500
3016998483Kegan Wellness-IndiaDrugs2020-07-13 00:00:00Warning Letter608737
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1000160561Stason Pharmaceuticals, Inc.CaliforniaUnited StatesDrugs2020-07-08 00:00:00Warning Letter604889
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3006211158Butterfly Expressions LlcIdahoUnited StatesDrugs2020-07-06 00:00:00Warning Letter608567
3016986351SinoTradition.com-ChinaDrugs2020-07-06 00:00:00Warning Letter608643
3016994540Lotus Herbal SupplementsOregonUnited StatesDrugs2020-07-06 00:00:00Warning Letter608658
3016994542Shijiazhuang Yiling Pharmaceutical Agent US, LLCOregonUnited StatesDrugs2020-07-06 00:00:00Warning Letter608658
3016994563Lianhuaqingwencaps.comSouth CarolinaUnited StatesDrugs2020-07-06 00:00:00Warning Letter608667
3012937475Front Door Pharmacy, LLC dba Pure Pharmacy (Pure Pharmaceuticals)TexasUnited StatesDrugs2020-07-01 00:00:00Warning Letter608461
3016994610Center for Wellness and Integrative MedicineCaliforniaUnited StatesDrugs2020-06-30 00:00:00Warning Letter608693
3012085912Epro E-Commerce Limited--Devices2020-06-29 00:00:00Warning Letter607657
3006028115Luminex CorporationIllinoisUnited StatesDevices2020-06-26 00:00:00Warning Letter606267
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3016986325Loyal Great International Ltd.--Drugs2020-06-26 00:00:00Warning Letter608633
3016946642Curativa Bay CorporationFloridaUnited StatesDrugs2020-06-25 00:00:00Warning Letter608406
3008420443Homeocare Laboratories, Inc.New YorkUnited StatesDrugs2020-06-22 00:00:00Warning Letter603532
3006489197Washington Homeopathic Products, Inc.West VirginiaUnited StatesDrugs2020-06-19 00:00:00Warning Letter589823
3016860064North Isle Wellness CenterNew YorkUnited StatesDrugs2020-06-19 00:00:00Warning Letter607947
3016936972Project 1600 Inc.New YorkUnited StatesDrugs2020-06-18 00:00:00Warning Letter608349
3015658387Vega Life Sciences-IndiaDrugs2020-06-17 00:00:00Warning Letter604469
3016823995Modern Allergy Management LLC dba Direct Med Solutions LLCFloridaUnited StatesDevices2020-06-17 00:00:00Warning Letter607769
3016693336KBMO DIAGNOSTICSMassachusettsUnited StatesDevices2020-06-17 00:00:00Warning Letter607822
3016810062antibodiescheck.com-United Arab EmiratesDevices2020-06-16 00:00:00Warning Letter607681
3016823857Sonrisa Family Dental dba www.mycovidtest19.comIllinoisUnited StatesDevices2020-06-16 00:00:00Warning Letter607748
3015617746Assurance InfusionTexasUnited StatesDrugs2020-06-12 00:00:00Warning Letter608360
3015908524Hevert Pharmaceuticals LLC USAColoradoUnited StatesDrugs2020-06-11 00:00:00Warning Letter594842
30100337978046255 Canada Inc. DBA Viatrexx-CanadaDrugs2020-06-11 00:00:00Warning Letter596178
1626962Medinatura New Mexico, inc.New MexicoUnited StatesDrugs2020-06-11 00:00:00Warning Letter596269
3007386694World Health Advanced Technologies LtdFloridaUnited StatesDrugs2020-06-11 00:00:00Warning Letter598247
1824619Centurion Medical Products, LPMichiganUnited StatesDevices2020-06-11 00:00:00Warning Letter598837
3008403546Centurion Medical Products, LPMichiganUnited StatesDevices2020-06-11 00:00:00Warning Letter598837
3004664162Takeda Pharmaceutical Company Limited-JapanDrugs2020-06-10 00:00:00Warning Letter603596
3016792440Medakit Ltd--Devices2020-06-10 00:00:00Warning Letter607603
3016920027www.outoftheboxremedies.com-IsraelDrugs2020-06-10 00:00:00Warning Letter608263
3010924627Mandell's Clinical PharmacyNew JerseyUnited StatesDrugs2020-06-10 00:00:00Warning Letter608320
3001236129Klarity Medical Products LLCOhioUnited StatesDevices2020-06-08 00:00:00Warning Letter606982
3016820952organic-beauty-recipes.com-CanadaDrugs2020-06-08 00:00:00Warning Letter607753
3000279201Creation Technologies Ltd-CanadaDevices2020-06-05 00:00:00Warning Letter608364
3009127876The Compounding PharmacyNorth CarolinaUnited StatesDrugs2020-06-05 00:00:00Warning Letter608400
3013913234EUCYT Laboratories LLCNevadaUnited StatesBiologics2020-06-04 00:00:00Warning Letter607182
3014539004CMC Enterprise PharmacyNorth CarolinaUnited StatesDrugs2020-06-04 00:00:00Warning Letter608036
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3003878590Cosmaceutical Research Lab Inc.-CanadaDrugs2020-05-29 00:00:00Warning Letter600121
3016790283Quadrant Sales & Marketing, Inc.FloridaUnited StatesDrugs2020-05-28 00:00:00Warning Letter607625
3016824094StayWell Copper ProductsColoradoUnited StatesDrugs2020-05-28 00:00:00Warning Letter607773
3016716640AlternavitaArizonaUnited StatesDrugs2020-05-26 00:00:00Warning Letter607147
3016733557CBD GazePuerto RicoUnited StatesDrugs2020-05-26 00:00:00Warning Letter607299
3016820731Musthavemom.comArizonaUnited StatesDrugs2020-05-26 00:00:00Warning Letter607749
3016821016Careful Cents, LLCColoradoUnited StatesDrugs2020-05-26 00:00:00Warning Letter607756
3008514611North Coast BiologicsWashingtonUnited StatesBiologics2020-05-21 00:00:00Warning Letter607532
3016826481Apollo Holding LLCSouth CarolinaUnited StatesDrugs2020-05-21 00:00:00Warning Letter607807
3016718098SpiceTacFloridaUnited StatesDrugs2020-05-19 00:00:00Warning Letter607144
3016820971Life Unlearned, LLCColoradoUnited StatesDrugs2020-05-19 00:00:00Warning Letter607754
3016815963Chloroquineonline.com-ChinaDrugs2020-05-18 00:00:00Warning Letter607725
2627511Fenwal International, Inc.Puerto RicoUnited StatesBiologics2020-05-15 00:00:00Warning Letter603610
3016774529Noetic NutraceuticalsMarylandUnited StatesDrugs2020-05-15 00:00:00Warning Letter607572
3016796235The Golden Road KratomCaliforniaUnited StatesDrugs2020-05-15 00:00:00Warning Letter607627
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3008342021Ideal Implant IncorporatedTexasUnited StatesDevices2020-05-14 00:00:00Warning Letter606103
30166087454nrx.mdCaliforniaUnited StatesDrugs2020-05-14 00:00:00Warning Letter606115
3016716643benjaminmcevoy.comMassachusettsUnited StatesDrugs2020-05-14 00:00:00Warning Letter607149
3009658676Montgomery Fertility CenterMarylandUnited StatesBiologics2020-05-14 00:00:00Warning Letter607345
3003348363Angiplast Private Limited-IndiaDevices2020-05-14 00:00:00Warning Letter607616
2011068Allergan Sales, LLCCaliforniaUnited StatesDevices2020-05-14 00:00:00Warning Letter607690
3016819761White Eagle Native HerbsArizonaUnited StatesDrugs2020-05-14 00:00:00Warning Letter607744
3008425092Samchundang Pharm Co., Ltd.--Drugs2020-05-13 00:00:00Warning Letter599255
3016784517Fusion Health and Vitality LLCGeorgiaUnited StatesDrugs2020-05-11 00:00:00Warning Letter607545
3014710073Seanjari Preeti Womb Healing, L.L.C.South CarolinaUnited StatesDrugs2020-05-08 00:00:00Warning Letter607355
3016790482Plum Dragon HerbsMarylandUnited StatesDrugs2020-05-08 00:00:00Warning Letter607629
3014538924Sanit Technologies, LLC dba DurisanFloridaUnited StatesDrugs2020-05-07 00:00:00Warning Letter606050
3016595998AgroTerra, Ltd. dba Patriot Hemp CompanyColoradoUnited StatesDrugs2020-05-07 00:00:00Warning Letter606086
3016622222WashingtonsLastFrontier.ComWashingtonUnited StatesDrugs2020-05-07 00:00:00Warning Letter606273
3016619648CHRONIC LYME TREATMENTS-CanadaDrugs2020-05-07 00:00:00Warning Letter607094
3014483112IntegraDose Compounding Services LLCMinnesotaUnited StatesDrugs2020-05-06 00:00:00Warning Letter592187
3015620544GlutaGenicFloridaUnited StatesDrugs2020-05-06 00:00:00Warning Letter607271
3015986368ALIVE BY NATURE LLCFloridaUnited StatesDrugs2020-05-06 00:00:00Warning Letter607435
3001744192Blaine Labs IncCaliforniaUnited StatesDrugs2020-05-05 00:00:00Warning Letter598733
3011495566Innovative Biodefense Inc.CaliforniaUnited StatesDrugs2020-05-04 00:00:00Injunction304
3003759643Indus Medicare Limited-IndiaDevices2020-05-04 00:00:00Warning Letter606159
3013503096HoneyColony LLCCaliforniaUnited StatesDrugs2020-05-04 00:00:00Warning Letter607346
3011108348Dr. Dhole's Sushanti Homeopathy Clinic-IndiaDrugs2020-05-04 00:00:00Warning Letter607348
3016608751Foxroids.comArizonaUnited StatesDrugs2020-04-30 00:00:00Warning Letter606131
3014332926Medlife Pharmacy and CompoundingCaliforniaUnited StatesDrugs2020-04-30 00:00:00Warning Letter607417
3016710297Hopewell Essential OilsTexasUnited StatesDrugs2020-04-27 00:00:00Warning Letter607088
3016733542Santiste Labs LLCPennsylvaniaUnited StatesDrugs2020-04-27 00:00:00Warning Letter607227
1000208853International Trading Pharm Lab IncNew JerseyUnited StatesDrugs2020-04-24 00:00:00Warning Letter598537
3009167769Kumar Organic Products Limited-IndiaDrugs2020-04-23 00:00:00Warning Letter598683
3007545534Prefense LLCIllinoisUnited StatesDrugs2020-04-23 00:00:00Warning Letter605488
3016608750Antroids.comCaliforniaUnited StatesDrugs2020-04-23 00:00:00Warning Letter606116
3016608768Roidsmall.netCaliforniaUnited StatesDrugs2020-04-23 00:00:00Warning Letter606133
3016609914Emedkit.com-IndiaDrugs2020-04-23 00:00:00Warning Letter606138
3016710767Copper Touch, LLCMinnesotaUnited StatesDrugs2020-04-21 00:00:00Warning Letter607176
3016560460Homero Corp DBA Natures CBD Oil DistributionNew HampshireUnited StatesDrugs2020-04-20 00:00:00Warning Letter605222
3000296486Carroll-Baccari, Inc.FloridaUnited StatesDevices2020-04-17 00:00:00Warning Letter598514
3001451379Greiner Bio-One North America, Inc.North CarolinaUnited StatesDevices2020-04-16 00:00:00Warning Letter606266
3016655220Nova Botanix LTD dba Cana BD-United KingdomDrugs2020-04-16 00:00:00Warning Letter606579
3003024060Sooil Development Co., Ltd.--Devices2020-04-16 00:00:00Warning Letter607127
3002808145Shriram Institute for Industrial Research-IndiaDrugs2020-04-15 00:00:00Warning Letter597629
3010003156The Art Of CureWashingtonUnited StatesDrugs2020-04-15 00:00:00Warning Letter606596
3016251538BIOTA Biosciences LLCWashingtonUnited StatesDrugs2020-04-14 00:00:00Warning Letter605164
3003941934Earth Angel OilsTexasUnited StatesDrugs2020-04-14 00:00:00Warning Letter605752
3012228225Tenderneeds Fertility LLCIndianaUnited StatesDevices2020-04-13 00:00:00Warning Letter603383
3016551424Alpha Arogya India Pvt. Ltd. (The GBS Group)-IndiaDrugs2020-04-13 00:00:00Warning Letter606253
3016661137Gaia Arise Farms ApothecaryNorth CarolinaUnited StatesDrugs2020-04-13 00:00:00Warning Letter606668
3016623261Herbs of Kedem-IsraelDrugs2020-04-10 00:00:00Warning Letter606835
3010641852Free Speech System LLC dba InfowarsTexasUnited StatesDrugs2020-04-09 00:00:00Warning Letter605802
3026016691Earthley WellnessOhioUnited StatesDrugs2020-04-09 00:00:00Warning Letter606525
3014461693HomeChoice Partners dba BioScript Infusion ServicesGeorgiaUnited StatesDrugs2020-04-09 00:00:00Warning Letter606962
3016527538NRP Organics Ltd-CanadaDrugs2020-04-08 00:00:00Warning Letter606066
3016648114Genesis 2 ChurchFloridaUnited StatesDrugs2020-04-08 00:00:00Warning Letter606459
3016590156Savvy Holistic HealthNorth CarolinaUnited StatesDrugs2020-04-07 00:00:00Warning Letter605915
3016655224CBD Online StoreCaliforniaUnited StatesDrugs2020-04-07 00:00:00Warning Letter606587
1221129Lymol Medical CorporationMassachusettsUnited StatesDevices2020-04-07 00:00:00Warning Letter606833
3016598453Alternative Health Experts, LLCCaliforniaUnited StatesDrugs2020-04-06 00:00:00Warning Letter605884
3016611689Cathay Natural, LLCMissouriUnited StatesDrugs2020-04-06 00:00:00Warning Letter606161
3011577681Ananda ApothecaryColoradoUnited StatesDrugs2020-04-06 00:00:00Warning Letter606163
3016622737Native Roots HempWisconsinUnited StatesDrugs2020-04-06 00:00:00Warning Letter606247
3016637469Indigo NaturalsCaliforniaUnited StatesDrugs2020-04-06 00:00:00Warning Letter606423
3015417637American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc.CaliforniaUnited StatesBiologics2020-04-02 00:00:00Warning Letter605068
3012315020TMC Acquisitions LLC dba Tailor Made CompoundingKentuckyUnited StatesDrugs2020-04-01 00:00:00Warning Letter594743
3016601904Homeomart Indibuy-IndiaDrugs2020-04-01 00:00:00Warning Letter605888
3016602544Health Mastery Systems DBA Pure Plant EssentialsOregonUnited StatesDrugs2020-04-01 00:00:00Warning Letter605890
3016601959Gaia's Whole Healing Essentials, LLCColoradoUnited StatesDrugs2020-04-01 00:00:00Warning Letter605893
3011785267Global Treat Srl-RomaniaDrugs2020-03-31 00:00:00Warning Letter596638
3016620414NeuroXPFNevadaUnited StatesDrugs2020-03-31 00:00:00Warning Letter606236
3014597434Pet Pharmacy NW LLCOregonUnited StatesDrugs2020-03-31 00:00:00Warning Letter606489
3016601935JRB Enterprise Group Inc. DBA Anti Aging BedSouth CarolinaUnited StatesDrugs2020-03-30 00:00:00Warning Letter605892
3005364634FullerLifeC60 LLCNevadaUnited StatesDrugs2020-03-30 00:00:00Warning Letter605954
3016610659Halosense Inc.-CanadaDrugs2020-03-30 00:00:00Warning Letter606153
3015850629University of KentuckyKentuckyUnited StatesDevices2020-03-26 00:00:00Warning Letter600258
3013944659CARAHEALTH-IrelandDrugs2020-03-26 00:00:00Warning Letter605826
3016599797Corona-cure.comArizonaUnited StatesDrugs2020-03-26 00:00:00Warning Letter605875
3008316085Pfizer Healthcare India Private Limited-IndiaDrugs2020-03-25 00:00:00Warning Letter594972
3015252551Invitrx Therapeutics Inc.CaliforniaUnited StatesBiologics2020-03-16 00:00:00Warning Letter581182
3014324616Hangzhou Linkeweier Daily Chemicals Co., Ltd.-ChinaDrugs2020-03-13 00:00:00Warning Letter595492
1000119582Altaire Pharmaceuticals, Inc.New YorkUnited StatesDrugs2020-03-12 00:00:00Warning Letter586153
3014480778Pharmcore Inc. dba Hallandale PharmacyFloridaUnited StatesDrugs2020-03-11 00:00:00Warning Letter605569
3005339091Windlas Healthcare Private Limited-IndiaDrugs2020-03-10 00:00:00Warning Letter595494
3005947959DermaPharm A/S-DenmarkDrugs2020-03-10 00:00:00Warning Letter596662
3012491944Trilogy Laboratories, LLCFloridaUnited StatesDrugs2020-03-09 00:00:00Warning Letter595087
3011849882Banco Vida Corp.Puerto RicoUnited StatesBiologics2020-03-09 00:00:00Warning Letter597197
3013861086Xephyr, LLC dba N-ErgeticsOklahomaUnited StatesDrugs2020-03-06 00:00:00Warning Letter604588
3016457658Vivify Holistic Clinic-CanadaDrugs2020-03-06 00:00:00Warning Letter604883
3013874743COLLOIDAL VITALITY LLCFloridaUnited StatesDrugs2020-03-06 00:00:00Warning Letter604885
3016548536Vital SilverFloridaUnited StatesDrugs2020-03-06 00:00:00Warning Letter604885
3014468707Gurunanda LLCCaliforniaUnited StatesDrugs2020-03-06 00:00:00Warning Letter604930
3016530400Quinessence Aromatherapy LTD-United KingdomDrugs2020-03-06 00:00:00Warning Letter605013
3007557677E-Care Technology Corp.-TaiwanDevices2020-03-02 00:00:00Warning Letter605117
3014115921FICOSOTA LTD-BulgariaDrugs2020-02-28 00:00:00Warning Letter594591
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3015275715James R. Corbett, M.D.MichiganUnited StatesDrugs2020-02-27 00:00:00Warning Letter603967
3005073828California IVF Fertility CenterCaliforniaUnited StatesBiologics2020-02-26 00:00:00Warning Letter598552
3014855979Natures Rx, LLCCaliforniaUnited StatesDrugs2020-02-24 00:00:00Warning Letter596516
1050658Mikart LLCGeorgiaUnited StatesDrugs2020-02-21 00:00:00Warning Letter605071
3010166880LEESAR, INCFloridaUnited StatesDrugs2020-02-18 00:00:00Warning Letter544728
3014466792ESSND GLOBAL-IndiaDrugs2020-02-14 00:00:00Warning Letter595850
3002806673Okamoto Rubber Products Co., Ltd.-ThailandDevices2020-02-14 00:00:00Warning Letter604564
3008846564Yibin Lihao Bio-technical Co., Ltd.-ChinaDrugs2020-02-13 00:00:00Warning Letter592503
3009223273JHS SVENDGAARD LABORATORIES LTD-IndiaDrugs2020-02-13 00:00:00Warning Letter593473
3004081307Cipla Limited-IndiaDrugs2020-02-12 00:00:00Warning Letter597511
1000115518Biomedix WaiMinnesotaUnited StatesDevices2020-02-12 00:00:00Warning Letter598171
3002806497Bedfont Scientific, Ltd.-United KingdomDevices2020-02-12 00:00:00Warning Letter604311
3005117563KVK-Tech, Inc.PennsylvaniaUnited StatesDrugs2020-02-11 00:00:00Warning Letter592387
3010165627Chemland Co., Ltd.--Drugs2020-02-11 00:00:00Warning Letter593158
3004723334Acino Products, LLCNew JerseyUnited StatesDrugs2020-02-10 00:00:00Warning Letter589471
3010172486Philosys Co. Ltd--Devices2020-02-05 00:00:00Warning Letter582516
1222117Unetixs Vascular, Inc.Rhode IslandUnited StatesDevices2020-02-04 00:00:00Warning Letter598016
3005138409Steiner Biotechnology LLCNevadaUnited StatesDevices2020-02-03 00:00:00Warning Letter592280
3010452718MANDELAY KFT-HungaryDevices2020-02-03 00:00:00Warning Letter603799
3007544618Guangzhou Tinci Materials Technology Co., Ltd.-ChinaDrugs2020-01-23 00:00:00Warning Letter592199
3015339284CPAPNEA Medical SupplyArizonaUnited StatesDevices2020-01-23 00:00:00Warning Letter592737
3009449945Sunstar Guangzhou Ltd.-ChinaDrugs2020-01-22 00:00:00Warning Letter592906
3005783425Draeger Medical Systems, Inc.MassachusettsUnited StatesDevices2020-01-17 00:00:00Warning Letter596529
1519176GOJO Industries IncOhioUnited StatesDrugs2020-01-17 00:00:00Warning Letter599132
3001623034Dental-Kosmetik GmbH & Co. KG-GermanyDrugs2020-01-16 00:00:00Warning Letter591351
3011425900R & B Medical Group Inc.CaliforniaUnited StatesBiologics2020-01-16 00:00:00Warning Letter596508
3008932054Tismor Health and Wellness Pty Limited-AustraliaDrugs2020-01-15 00:00:00Warning Letter588104
3014877770Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyTennesseeUnited StatesDrugs2020-01-14 00:00:00Warning Letter598303
3015393587Wave Miami LLCPennsylvaniaUnited StatesDrugs2020-01-13 00:00:00Warning Letter590422
3009647084Cosmelab Co Ltd--Drugs2020-01-09 00:00:00Warning Letter590480
3007628845Huaian Zongheng Bio-Tech Co., Ltd-ChinaDrugs2020-01-09 00:00:00Warning Letter590789
3013761135Zhuhai Aofute Medical Technology Co., Ltd.-ChinaDrugs2020-01-09 00:00:00Warning Letter590945
3015358337James W. Findling, M.D.WisconsinUnited StatesDrugs2019-12-31 00:00:00Warning Letter598944
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3003173295Apollo Health And Beauty Care, Inc.-CanadaDrugs2019-12-23 00:00:00Warning Letter593033
3011897170Global Medical Technology SL-SpainDevices2019-12-20 00:00:00Warning Letter598226
3008527957CGA Limited--Drugs2019-12-19 00:00:00Warning Letter589028
3011524753Jiangsu JDC Medical Devices Co., Ltd.-ChinaDevices2019-12-19 00:00:00Warning Letter598340
3013856804Health Pharma USA LLCNew JerseyUnited StatesDrugs2019-12-18 00:00:00Warning Letter588155
1000525249Cross Brands Contract Filling, LLCFloridaUnited StatesDrugs2019-12-17 00:00:00Warning Letter589295
3008311641GPT Pharmaceuticals Private Ltd-IndiaDrugs2019-12-17 00:00:00Warning Letter590938
3012285699MBB Production Mexico S. de R.L. de C.V.-MexicoDrugs2019-12-13 00:00:00Warning Letter590791
3014268427CureWave Lasers, LLCTexasUnited StatesDevices2019-12-12 00:00:00Warning Letter593692
2027600Soaptronic LLCCaliforniaUnited StatesDrugs2019-12-12 00:00:00Warning Letter596450
3004797270Pharmalab Enterprises, Inc.FloridaUnited StatesDrugs2019-12-10 00:00:00Warning Letter588432
3004153240Conformis Inc.MassachusettsUnited StatesDevices2019-12-10 00:00:00Warning Letter596362
3005404127Zona Health Inc.AlabamaUnited StatesDevices2019-12-06 00:00:00Warning Letter584676
3006210769Wild Child Laboratories Pty Ltd.-AustraliaDrugs2019-12-06 00:00:00Warning Letter589463
3015381220Liveyon Labs IncCaliforniaUnited StatesBiologics2019-12-05 00:00:00Warning Letter588399
3425USHIO GERMANY GmbH-GermanyDevices2019-12-04 00:00:00Warning Letter596106
3009271465Henan Kangdi Medical Devices Co. Ltd-ChinaDrugs2019-12-03 00:00:00Warning Letter587699
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3008350682Ningbo BST Clean and Care Products Co., Ltd-ChinaDrugs2019-11-27 00:00:00Warning Letter587788
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3015462399The CBD Store, LLCFloridaUnited StatesDrugs2019-11-22 00:00:00Warning Letter585390
3015672788INFINITE PRODUCT COMPANY LLLPColoradoUnited StatesDrugs2019-11-22 00:00:00Warning Letter593175
3015810316Whole Leaf Organics, LLCCaliforniaUnited StatesDrugs2019-11-22 00:00:00Warning Letter593176
3015153475KOI CBD, LLCCaliforniaUnited StatesDrugs2019-11-22 00:00:00Warning Letter593391
3013631470MR. PINK COLLECTIONS, LLCCaliforniaUnited StatesDrugs2019-11-22 00:00:00Warning Letter593395
3015831279Noli Oil, LLCTexasUnited StatesDrugs2019-11-22 00:00:00Warning Letter593497
3015861842Bella Rose LabsNew YorkUnited StatesDrugs2019-11-22 00:00:00Warning Letter594246
3003231743OHM Pharma, Inc.TexasUnited StatesDrugs2019-11-19 00:00:00Warning Letter586428
3007291509Grace Analytical Lab IncIllinoisUnited StatesDrugs2019-11-19 00:00:00Warning Letter586510
3015603814EPH Technologies, Inc.New MexicoUnited StatesDrugs2019-11-18 00:00:00Warning Letter590707
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3009189894American Contract Systems, Inc.TexasUnited StatesDevices2019-11-09 00:00:00Warning Letter595573
3001746542Apothecus Pharmaceutical Corp.New YorkUnited StatesDrugs2019-11-08 00:00:00Warning Letter585666
3004007943A.P. Deauville, LLCPennsylvaniaUnited StatesDrugs2019-11-08 00:00:00Warning Letter586306
3005269673Greenbrier International, IncVirginiaUnited StatesDrugs2019-11-07 00:00:00Warning Letter574706
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3003343209Reproductive Technologies, Inc.CaliforniaUnited StatesBiologics2019-11-06 00:00:00Warning Letter594292
3002785310Tianish Laboratories Private Limited-IndiaDrugs2019-11-05 00:00:00Warning Letter589297
3003053677Swabplus, L.P.CaliforniaUnited StatesDrugs2019-10-31 00:00:00Warning Letter584803
3002984011ZYDUS LIFESCIENCES LIMITED-IndiaDrugs2019-10-29 00:00:00Warning Letter584856
3003972438Strong Fertility CenterNew YorkUnited StatesBiologics2019-10-29 00:00:00Warning Letter593262
3004536846Apozeal Pharmaceuticals Inc.PennsylvaniaUnited StatesDrugs2019-10-28 00:00:00Warning Letter584701
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3004881534Hubei Danao Pharmaceutical Co., Ltd.-ChinaDrugs2017-11-06 00:00:00Warning Letter539667
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3012188090Option Care EnterprisesIllinoisUnited StatesDrugs2017-09-28 00:00:00Warning Letter538040
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3012773475Ladd Family Pharmacy LLCIdahoUnited StatesDrugs2017-09-26 00:00:00Warning Letter516046
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3006989780Euro-Med Laboratories Phil-PhilippinesDrugs2017-09-25 00:00:00Injunction296
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3002128313SANUM-Kehlbeck GmbH & Co. KG-GermanyDrugs2014-04-11 00:00:00Warning Letter406594
3004201275Sanmina-SCI AB-SwedenDevices2014-04-11 00:00:00Warning Letter423189
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3010275991Advanced Interventional Pain Ctr IRBIndianaUnited StatesDevices2014-02-07 00:00:00Warning Letter416383
3003255171USV Private Limited-IndiaDrugs2014-02-06 00:00:00Warning Letter413332
3004018643Heartsine Technologies IncPennsylvaniaUnited StatesDevices2014-02-03 00:00:00Warning Letter415706
3008746159CBSCHEM LIMITED--Drugs2014-01-31 00:00:00Warning Letter408698
3009073476CBSCHEM LimitedArizonaUnited StatesDrugs2014-01-31 00:00:00Warning Letter409770
3010365769Slim Beauty USANebraskaUnited StatesDrugs2014-01-31 00:00:00Warning Letter418145
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2026154Amgen, Inc.CaliforniaUnited StatesDrugs2014-01-27 00:00:00Warning Letter414230
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3010533023Lucky Beauty Equipment Co., LTD.-ChinaDevices2014-01-15 00:00:00Warning Letter417003
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3003353805Obstetrics Gynecology, LtdArkansasUnited StatesDevices2014-01-10 00:00:00Warning Letter419163
3002807642Mapa Gmbh-GermanyDevices2013-12-31 00:00:00Warning Letter415564
3010145623Ana J. FandinoFloridaUnited StatesDrugs2013-12-31 00:00:00Warning Letter416633
3003888399Philips HealthcareCaliforniaUnited StatesDevices2013-12-20 00:00:00Warning Letter414361
3003742580DNA Genotek Inc.-CanadaDevices2013-12-20 00:00:00Warning Letter416225
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3004715583Subcon Manufacturing CorporationIllinoisUnited StatesDevices2013-12-16 00:00:00Warning Letter375498
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3003202721Racer Technology Pte Ltd-SingaporeDevices2013-12-12 00:00:00Warning Letter411740
3008921663SKINREX CO., LTD--Devices2013-12-12 00:00:00Warning Letter414838
3006066935Coastal Contacts Inc.-CanadaDevices2013-12-11 00:00:00Warning Letter411966
3004839934Ralco S.R.L.-ItalyDevices2013-12-06 00:00:00Warning Letter415275
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3009973354Sunshine USA, LLCTennesseeUnited StatesDevices2013-12-05 00:00:00Warning Letter416629
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3010477Jubilant HollisterStier LLCWashingtonUnited StatesDrugs2013-11-27 00:00:00Warning Letter406275
1824975St Vincent HealthIndianaUnited StatesDrugs2013-11-27 00:00:00Warning Letter413473
3015876Physio-Control, Inc.WashingtonUnited StatesDevices2013-11-26 00:00:00Injunction191
3003187221San Up S.A.-ArgentinaDevices2013-11-25 00:00:00Warning Letter410642
3009352034Sharplight Technologies-IsraelDevices2013-11-25 00:00:00Warning Letter411909
3002808503Wockhardt Limited-IndiaDrugs2013-11-25 00:00:00Warning Letter412858
3004595684Trokamed GmbH-GermanyDevices2013-11-22 00:00:00Warning Letter414184
300769945923andMe, Inc.CaliforniaUnited StatesDevices2013-11-22 00:00:00Warning Letter415534
3010157687Agnes E. Ubani, MDFloridaUnited StatesDrugs2013-11-21 00:00:00Warning Letter414839
3002731916Shoney Scientific India-IndiaDevices2013-11-20 00:00:00Warning Letter411720
3007674911Hyperion Medical Technologies IncTexasUnited StatesDevices2013-11-20 00:00:00Warning Letter411723
3004753417Manhattan Reproductive Medicine, PCNew YorkUnited StatesBiologics2013-11-20 00:00:00Warning Letter413797
3010026564Sreedhar SamudralaTennesseeUnited StatesDrugs2013-11-19 00:00:00Warning Letter412640
3010026564Sreedhar SamudralaTennesseeUnited StatesDrugs2013-11-19 00:00:00Warning Letter413699
3008713077SYNECCO CO. LTD.-ChinaDevices2013-11-18 00:00:00Warning Letter410611
3009456664Three Rivers Pharmaceuticals LLCPennsylvaniaUnited StatesDrugs2013-11-18 00:00:00Warning Letter413478
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2183456Ad-Tech Medical Instrument CorporationWisconsinUnited StatesDevices2013-11-14 00:00:00Warning Letter410052
3002806674Cheen Houng Enterprise Co., Ltd.-TaiwanDevices2013-11-14 00:00:00Warning Letter411274
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3010410827Clinical Lasers, Inc.DelawareUnited StatesDevices2013-11-14 00:00:00Warning Letter412317
3009569098Amryt Pharmaceuticals, Inc.MassachusettsUnited StatesDrugs2013-11-08 00:00:00Warning Letter414770
3009801653Aptalis Pharma Us IncAlabamaUnited StatesDevices2013-10-25 00:00:00Warning Letter413496
3009668937Avacen Inc.CaliforniaUnited StatesDevices2013-10-23 00:00:00Warning Letter410535
3001657382R82 A/S-DenmarkDevices2013-10-18 00:00:00Warning Letter412111
3004775225Virtual Sun, LLCNorth CarolinaUnited StatesDevices2013-10-09 00:00:00Warning Letter412511
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1824226King Systems Corp. dba Ambu, Inc.IndianaUnited StatesDevices2013-09-30 00:00:00Warning Letter411393
3005466331C.P.M. Contract Pharma GmbH & Co. KG-GermanyDrugs2013-09-30 00:00:00Warning Letter412352
3004142400Globus Medical, Inc.PennsylvaniaUnited StatesDevices2013-09-26 00:00:00Warning Letter408025
2010939Hyland's Consumer Health Inc.CaliforniaUnited StatesDrugs2013-09-25 00:00:00Warning Letter407607
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3002807715NIDEK Co., Ltd.-JapanDevices2013-09-24 00:00:00Warning Letter410944
3003503128American Aesthetics Medical Supply, Inc.TexasUnited StatesDevices2013-09-23 00:00:00Warning Letter397346
3003749234Batrik Medical Mfg., Inc.-CanadaDevices2013-09-23 00:00:00Warning Letter410595
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3004569035Insight Pharmaceuticals CorporationPennsylvaniaUnited StatesDrugs2013-09-19 00:00:00Warning Letter398199
1000399435Homeolab USA Inc.-CanadaDrugs2013-09-19 00:00:00Warning Letter398217
1719513Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare companyNew YorkUnited StatesDrugs2013-09-19 00:00:00Warning Letter398226
1481571Topco Associates LLCIllinoisUnited StatesDrugs2013-09-19 00:00:00Warning Letter398232
3003166194Medtronic MiniMed, Inc.CaliforniaUnited StatesDevices2013-09-19 00:00:00Warning Letter405884
3007738846ANJI ZHENGBANG MEDICAL INSTRUMENT CO, LTD-ChinaDevices2013-09-19 00:00:00Warning Letter409682
2317393General Hearing Instruments IncLouisianaUnited StatesDevices2013-09-18 00:00:00Warning Letter411835
3006359068Shamrock Medical Solutions Group LLCOhioUnited StatesDrugs2013-09-17 00:00:00Injunction250
3007962592Suzhou Armocon Technology Co.Ltd-ChinaDevices2013-09-16 00:00:00Warning Letter408940
3003289691Epflex Feinwerktechnik GmbH-GermanyDevices2013-09-16 00:00:00Warning Letter409621
3009885851Dimitri Sirakoff, D.O.CaliforniaUnited StatesDrugs2013-09-12 00:00:00Warning Letter409154
2519945Neurolign USA, LlcPennsylvaniaUnited StatesDevices2013-09-11 00:00:00Warning Letter410822
3003939253Virginia Center for Reproductive MedicineVirginiaUnited StatesBiologics2013-09-10 00:00:00Warning Letter409387
3007648351Mylan Laboratories Limited-IndiaDrugs2013-09-09 00:00:00Warning Letter409756
3004050971Vincent Medical (Dong Guan) Manufacturing Co., Ltd.-ChinaDevices2013-09-05 00:00:00Warning Letter408035
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3006306504FVS Holdings, Inc. dba. Green Valley DrugsNevadaUnited StatesDrugs2013-08-30 00:00:00Warning Letter409768
3002806778Agilent Technologies Denmark ApS-DenmarkDevices2013-08-29 00:00:00Warning Letter406109
3007166802Prothya Biosolutions Netherlands B.V.-NetherlandsBiologics2013-08-29 00:00:00Warning Letter409469
3007166786CAF-DAF scrl-BelgiumBiologics2013-08-29 00:00:00Warning Letter411102
1721400Dakota Laboratories, LLCSouth DakotaUnited StatesDrugs2013-08-26 00:00:00Injunction238
3003569504Jabones Pardo S.A.-SpainDrugs2013-08-26 00:00:00Warning Letter398208
3005841978Bio Focus Co. Ltd.--Devices2013-08-26 00:00:00Warning Letter407508
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3009499974Celltex Therapeutics CorporationTexasUnited StatesBiologics2012-09-24 00:00:00Warning Letter306519
3003008014Texas Applied Biotechnology Research Review CommitteeTexasUnited StatesBiologics2012-09-24 00:00:00Warning Letter324258
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3004006654Evangelical Christian Ministry dba Health & HerbsTexasUnited StatesDrugs2012-09-20 00:00:00Injunction229
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3009718178Arkadiy KisinCaliforniaUnited StatesDrugs2012-09-18 00:00:00Warning Letter346258
3009725255Eyal Bar Oz-IsraelDrugs2012-09-18 00:00:00Warning Letter347818
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2429304Olympus Corporation of the AmericasPennsylvaniaUnited StatesDevices2012-09-10 00:00:00Warning Letter353038
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3003803331Unisis Corp.-JapanDevices2012-09-07 00:00:00Warning Letter327798
3005858500Quzhou Chemsyn Pharm Co Ltd-ChinaDrugs2012-09-06 00:00:00Warning Letter357778
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3009506643Synergy Health Concepts, Inc.CaliforniaUnited StatesDevices2012-09-05 00:00:00Warning Letter327419
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3006802322YANG MING INDUSTRY (ZHEJIANG) LIMITED-ChinaDevices2012-08-15 00:00:00Warning Letter325498
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3003191210Dongguan Sure On Plastic & Fiber Products Co., LTD.-ChinaDevices2012-08-06 00:00:00Warning Letter319538
3009346747Prince Medical Industry SUARL-TunisiaDevices2012-08-03 00:00:00Warning Letter321958
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3004752776Compumedics Germany Gmbh-GermanyDevices2012-08-01 00:00:00Warning Letter327299
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3005988718AireRx Healthcare, LLCTennesseeUnited StatesDevices2012-07-30 00:00:00Warning Letter313279
3009417634Damien Sanderlin, MDTexasUnited StatesBiologics2012-07-27 00:00:00Warning Letter328099
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1000605000Royal King Infant Products Co., Ltd.-ThailandDevices2012-07-26 00:00:00Warning Letter319199
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3004023840Arriol International Corp.--Devices2012-07-20 00:00:00Warning Letter314339
3003764019Meditech KFT-HungaryDevices2012-07-18 00:00:00Warning Letter314858
2024312Kerr CorporationCaliforniaUnited StatesDevices2012-07-17 00:00:00Warning Letter313518
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3006368133Gooten Innolife Corp-TaiwanDevices2012-07-16 00:00:00Warning Letter307238
3006716626NINGBO HUAHUI MEDICAL INSTRUMENTS CO., LTD.-ChinaDevices2012-07-16 00:00:00Warning Letter314879
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3004181270Quantum Devices, Inc.WisconsinUnited StatesDevices2012-07-12 00:00:00Warning Letter310758
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3002807462Leisegang Feinmechanick-Optik GmbH-GermanyDevices2012-07-11 00:00:00Warning Letter305239
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3008058540Infupharma LLC d.b.a. President PharmacyFloridaUnited StatesDrugs2012-07-09 00:00:00Warning Letter259194
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3006228598Wells Pharmacy Network LLCFloridaUnited StatesDrugs2012-07-09 00:00:00Warning Letter313339
3008814204Center for the Improvement of Human Functioning Intl IRBKansasUnited StatesDrugs2012-07-03 00:00:00Warning Letter314719
3005566827Changzhou Wujin Zhengping Shuangma Chemical Plant-ChinaDrugs2012-07-03 00:00:00Warning Letter318058
2517506Siemens Healthcare Diagnostics, Inc.DelawareUnited StatesDevices2012-06-29 00:00:00Warning Letter285520
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3007912046Apia Enterprise IncCaliforniaUnited StatesDevices2012-06-28 00:00:00Warning Letter294497
3006621386Guangdong Baihe Medical Technology Co., Ltd-ChinaDevices2012-06-27 00:00:00Warning Letter314978
3006617512Dongguan Yong Rong Plastics Co. Ltd.-ChinaDevices2012-06-27 00:00:00Warning Letter315618
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3008113239Pinook USA, LLCFloridaUnited StatesDevices2012-06-14 00:00:00Warning Letter292797
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3005892317CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd-ChinaDrugs2012-06-14 00:00:00Warning Letter322099
3002775853Compania Internacional de Comercio, S.A.P.I. de C.V.-MexicoDrugs2012-06-13 00:00:00Warning Letter277998
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3003365815Valeant Amsterdam Logistics Center-NetherlandsDevices2012-06-11 00:00:00Warning Letter222380
3002809480Oertel Medical GmbH-GermanyDevices2012-06-11 00:00:00Warning Letter303918
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3006785507Zhucheng Haotian Pharm Co. Ltd.-ChinaDrugs2012-06-11 00:00:00Warning Letter318040
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2627511Fenwal International, Inc.Puerto RicoUnited StatesBiologics2012-06-01 00:00:00Warning Letter306980
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2432235Siemens Healthcare Diagnostics, Inc.New YorkUnited StatesDevices2012-05-29 00:00:00Warning Letter270716
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3004036103Pharmawest Pharmacy Ltd-CanadaDrugs2012-05-24 00:00:00Warning Letter297239
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2416101Pfizer Inc.New YorkUnited StatesDrugs2012-05-24 00:00:00Warning Letter301979
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3004518843Chinese Peptide Company-ChinaDrugs2012-05-21 00:00:00Warning Letter284739
3007343484Gramercy Fertility ServicesNew YorkUnited StatesBiologics2012-05-18 00:00:00Warning Letter296897
3008817603Arrowhead DE LLCGeorgiaUnited StatesDevices2012-05-18 00:00:00Warning Letter301261
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3004146033Octapharma USA, Inc.New JerseyUnited StatesBiologics2012-05-17 00:00:00Warning Letter294798
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3002444944Copan Italia-ItalyDevices2012-05-14 00:00:00Warning Letter303078
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1219913Siemens Healthcare Diagnostics, Inc.MassachusettsUnited StatesDevices2012-05-10 00:00:00Warning Letter270001
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3005998761BTS S.p.A.-ItalyDevices2012-05-10 00:00:00Warning Letter287878
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3004102031Terumo Medical Products (Hangzhou) Co., Ltd.-ChinaDevices2012-05-09 00:00:00Warning Letter277698
3003283395Mediagnost GmbH-GermanyDevices2012-05-09 00:00:00Warning Letter285197
3003005746Quadex Pharmaceuticals, LlcUtahUnited StatesDrugs2012-05-07 00:00:00Warning Letter249554
3006059917Stingray Surgical Products, LLCFloridaUnited StatesDevices2012-05-07 00:00:00Warning Letter273796
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3004213967Productos Urologos de Mexico, S.A. de C.V.-MexicoDevices2012-05-07 00:00:00Warning Letter287859
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3003138182Amplivox Ltd-United KingdomDevices2012-05-02 00:00:00Warning Letter290397
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1077496OneBlood, Inc.FloridaUnited StatesBiologics2012-04-27 00:00:00Warning Letter285017
3003184440Tedec-Meiji Farma, S.A.-SpainDrugs2012-04-24 00:00:00Warning Letter243054
3002174993B.M.P. Bulk Medicines & Pharmaceuticals GmbH-GermanyDrugs2012-04-24 00:00:00Warning Letter287998
3009297906Thomas E. Young, MD, LLCPennsylvaniaUnited StatesBiologics2012-04-20 00:00:00Warning Letter278418
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3003144790Korea Pharma Co., Ltd.--Drugs2012-03-26 00:00:00Warning Letter292537
3005140091NuSil Technology LLCCaliforniaUnited StatesDrugs2012-03-23 00:00:00Warning Letter201532
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3002847480Heartway Medical Products Co., Ltd.-TaiwanDevices2012-03-07 00:00:00Warning Letter270236
3007486998Osypka Medical Gmbh-GermanyDevices2012-03-07 00:00:00Warning Letter271536
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3003263118Pan Drugs Ltd.-IndiaDrugs2012-02-28 00:00:00Warning Letter284758
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3004504829Gulf Pharmaceutical Industries - Julphar-United Arab EmiratesDrugs2012-02-23 00:00:00Warning Letter257094
3004960482Elcam Medical Italy SPA-ItalyDevices2012-02-23 00:00:00Warning Letter257195
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1000110325Fukuda Denshi Co, Ltd-JapanDevices2012-02-21 00:00:00Warning Letter265376
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3002807978Sun Pharmaceutical Industries (prev. Ranbaxy)-IndiaDrugs2012-01-25 00:00:00Injunction234
3001551314Zhejiang Xianju Chemical Pharmaceutical Factory-ChinaDrugs2012-01-25 00:00:00Warning Letter278397
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3002807267Intersurgical, Ltd.-United KingdomDevices2011-12-30 00:00:00Warning Letter251294
3002806673Okamoto Rubber Products Co., Ltd.-ThailandDevices2011-12-30 00:00:00Warning Letter254174
3006257509Changzhou Jialing Medicine Industry Co. Ltd.-ChinaDrugs2011-12-29 00:00:00Warning Letter271317
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3002807099Go Medical Industries Pty., Ltd.-AustraliaDevices2011-12-23 00:00:00Warning Letter241874
3002807465BLANCHARD VISION CORP.-CanadaDevices2011-12-23 00:00:00Warning Letter249294
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3002806808Diagnostic Biochem Canada Inc.-CanadaDevices2011-12-20 00:00:00Warning Letter251194
3005144590Medpharm, LLCVirginiaUnited StatesDrugs2011-12-20 00:00:00Warning Letter270156
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3008985101Lasik Vision InstituteWashingtonUnited StatesDevices2011-12-16 00:00:00Warning Letter215574
3002807481Labor LS SE & Co. KG-GermanyDrugs2011-12-16 00:00:00Warning Letter218874
3009070428Newman Lasik Centers, LLCCaliforniaUnited StatesDevices2011-12-16 00:00:00Warning Letter247154
3002806906Merck KGaA-GermanyDrugs2011-12-15 00:00:00Warning Letter214335
3002807447Merck Serono SA-SwitzerlandDrugs2011-12-15 00:00:00Warning Letter214335
1022129KBD, Inc.NevadaUnited StatesDevices2011-12-15 00:00:00Warning Letter216414
3002806906Merck KGaA-GermanyDrugs2011-12-15 00:00:00Warning Letter216834
3003131678Merck Serono SA (Vevey)-SwitzerlandDrugs2011-12-15 00:00:00Warning Letter216834
3002806906Merck KGaA-GermanyDrugs2011-12-15 00:00:00Warning Letter220954
3002807252Merck Serono S.p.A.-ItalyDrugs2011-12-15 00:00:00Warning Letter220954
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3006139622Spencer ForrestCaliforniaUnited StatesDevices2011-12-09 00:00:00Warning Letter240694
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3008920538Natural Medical Supply, LLCUtahUnited StatesDrugs2011-11-28 00:00:00Warning Letter192773
3008920562Rightway Nutrition, LLCUtahUnited StatesDrugs2011-11-28 00:00:00Warning Letter192774
3009800828Creative Bioscience, LLCUtahUnited StatesDrugs2011-11-28 00:00:00Warning Letter192775
3008886372Hcg-miracleweightloss.comIdahoUnited StatesDrugs2011-11-28 00:00:00Warning Letter192776
3008889379Theoriginalhcgdrogs.comNew YorkUnited StatesDrugs2011-11-28 00:00:00Warning Letter192777
3008887008HCG Diet Direct, LLCArizonaUnited StatesDrugs2011-11-28 00:00:00Warning Letter192934
3002807135H & A Mui Enterprises, Inc.-CanadaDevices2011-11-22 00:00:00Warning Letter227795
1119234Medical Supplies CorporationMarylandUnited StatesDevices2011-11-21 00:00:00Warning Letter216896
1717759Sandoz IncorporatedNew JerseyUnited StatesDrugs2011-11-18 00:00:00Warning Letter197272
3003507481Osmed Gmbh-GermanyDevices2011-11-18 00:00:00Warning Letter232556
3000280957Delpharm Boucherville Canada, Inc.-CanadaDrugs2011-11-18 00:00:00Warning Letter233134
3002807772Novartis Pharma AG-SwitzerlandDrugs2011-11-18 00:00:00Warning Letter233134
3008817713Moko Therapeutics, LLCCaliforniaUnited StatesDrugs2011-11-17 00:00:00Warning Letter187632
1000119582Altaire Pharmaceuticals, Inc.New YorkUnited StatesDrugs2011-11-16 00:00:00Warning Letter198292
3002616951Rose Stone EnterprisesCaliforniaUnited StatesDrugs2011-11-16 00:00:00Warning Letter198392
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3003882630Nouryon Chemicals, S.A. de C.V.-MexicoDrugs2011-11-16 00:00:00Warning Letter218634
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3004374705Aerolase Corp.New YorkUnited StatesDevices2011-11-16 00:00:00Warning Letter220714
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1000414342Ever Pharma Jena GmbH-GermanyDrugs2011-10-19 00:00:00Warning Letter198112
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2650176Auro PR IncPuerto RicoUnited StatesDrugs2011-10-13 00:00:00Warning Letter187532
3002808026Rocket Medical Plc-United KingdomDevices2011-10-13 00:00:00Warning Letter217075
1000175127Topcon Corporation-JapanDevices2011-10-12 00:00:00Warning Letter175513
3005615655Jazz Pharmaceuticals, IncCaliforniaUnited StatesDrugs2011-10-12 00:00:00Warning Letter192992
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2518422Philips Respironics, Inc.PennsylvaniaUnited StatesDevices2011-10-11 00:00:00Warning Letter209393
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3001227743Oridion Medical 1987 Ltd.-IsraelDevices2011-10-04 00:00:00Warning Letter219475
3007510735Advantageous MD LlcVirginiaUnited StatesDevices2011-10-04 00:00:00Warning Letter229274
3002807717Cantor & Nissel Ltd.-United KingdomDevices2011-09-27 00:00:00Warning Letter207433
3003829675Dongguan Polygreen Technology Co., Ltd.-ChinaDevices2011-09-27 00:00:00Warning Letter214974
3009094017Galyna / Ivan Podornikova-UkraineDrugs2011-09-27 00:00:00Warning Letter216614
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1036365Hill Dermaceuticals, Inc.FloridaUnited StatesDrugs2011-09-26 00:00:00Injunction335
3002806315Aesculap AG-GermanyDevices2011-09-26 00:00:00Warning Letter205233
3009093992SPHERE Inc.New YorkUnited StatesDrugs2011-09-26 00:00:00Warning Letter216594
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1413475Dental Technologies Inc.IllinoisUnited StatesDrugs2011-09-15 00:00:00Warning Letter187653
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3003472235Hospital Bella VistaPuerto RicoUnited StatesDevices2011-09-13 00:00:00Warning Letter379818
3002808073Sichuan Pharmaceutical Co., Ltd.-ChinaDrugs2011-09-12 00:00:00Warning Letter209813
3004896339Yag Mag Labs Private Limited-IndiaDrugs2011-09-12 00:00:00Warning Letter213033
2918644United Contact Lens, Inc.WashingtonUnited StatesDevices2011-09-09 00:00:00Warning Letter206513
3000205843RX Air Industries LLC.TexasUnited StatesDevices2011-09-08 00:00:00Warning Letter265975
1000160433Covenant Medical Center Inc.MichiganUnited StatesDrugs2011-09-07 00:00:00Warning Letter209973
1000279065Moor Instruments Ltd-United KingdomDevices2011-09-06 00:00:00Warning Letter211373
1416923Deibel Laboratories of Illinois, Inc.IllinoisUnited StatesDrugs2011-09-01 00:00:00Warning Letter192913
3001701602Lonza Biologics, Inc.MassachusettsUnited StatesDrugs2011-09-01 00:00:00Warning Letter195672
2410375American Regent, Inc.New YorkUnited StatesDrugs2011-08-31 00:00:00Warning Letter182994
1017687PAI Holdings, LLC. dba Pharmaceutical Associates IncSouth CarolinaUnited StatesDrugs2011-08-29 00:00:00Warning Letter183834
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3006433555Stryker Medical London dba CHG Hospital Beds-CanadaDevices2011-08-29 00:00:00Warning Letter204934
3006433555Stryker Medical London dba CHG Hospital Beds-CanadaDevices2011-08-29 00:00:00Warning Letter205092
3008416529Micro Distributing I I, LtdTexasUnited StatesDevices2011-08-26 00:00:00Warning Letter192972
3002806833Dornier Medtech Systems GmbH-GermanyDevices2011-08-26 00:00:00Warning Letter203432
3008420267John Caton JrOregonUnited StatesDrugs2011-08-26 00:00:00Warning Letter205673
3005201285Noven Pharmaceuticals, Inc.CaliforniaUnited StatesDrugs2011-08-25 00:00:00Warning Letter173292
3003843036Galloway Technologies, LLCUtahUnited StatesDevices2011-08-25 00:00:00Warning Letter175552
3008263944Sam-go ProductsTexasUnited StatesDevices2011-08-24 00:00:00Warning Letter198152
1925312ThyssenKrupp Access CorpMissouriUnited StatesDevices2011-08-23 00:00:00Warning Letter177872
3003813327Uriel Pharmacy, IncWisconsinUnited StatesDrugs2011-08-18 00:00:00Warning Letter161712
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3008829548TCA Cellular Therapy, LLCLouisianaUnited StatesBiologics2011-08-15 00:00:00Warning Letter202252
3008820147GD Designs, Inc.CaliforniaUnited StatesDevices2011-08-12 00:00:00Warning Letter185575
3006989604Yale M Cohen, MDFloridaUnited StatesDrugs2011-08-12 00:00:00Warning Letter206213
3007025733THEROZONE USA, INC.CaliforniaUnited StatesDevices2011-08-11 00:00:00Warning Letter180272
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3004486512Miramar Cosmetics, IncFloridaUnited StatesDrugs2011-08-08 00:00:00Warning Letter173212
3007925588Zhejiang Casing Animal By-Products Co.,Ltd.-ChinaDrugs2011-08-05 00:00:00Warning Letter170612
3008548567Nanjing Maohai Biotech Co.-ChinaDrugs2011-08-05 00:00:00Warning Letter171833
3001452136Superstat CorporationCaliforniaUnited StatesDevices2011-08-05 00:00:00Warning Letter195313
3006488062Cel-Sci CorporationVirginiaUnited StatesDrugs2011-08-05 00:00:00Warning Letter205172
2523170Airpal, Inc.IllinoisUnited StatesDevices2011-08-04 00:00:00Warning Letter193632
3006723646Hoya Surgical Optics, Inc.CaliforniaUnited StatesDevices2011-08-02 00:00:00Warning Letter175472
3002808267LivaNova Deutschland GmbH-GermanyDevices2011-08-02 00:00:00Warning Letter206153
2050012Beckman Coulter Inc.CaliforniaUnited StatesDevices2011-08-01 00:00:00Warning Letter194932
2241583Pharmaceutical Innovations, Inc.New JerseyUnited StatesDevices2011-07-29 00:00:00Warning Letter205932
3003768921Gulf Fiberoptics, Inc.FloridaUnited StatesDevices2011-07-28 00:00:00Warning Letter195372
3003681187Bionet Co., Ltd.--Devices2011-07-27 00:00:00Warning Letter197392
3002807450Laboratorios B. Braun S.A.-BrazilDevices2011-07-26 00:00:00Warning Letter187013
2246448Essex Institutional Review Board, IncNew JerseyUnited StatesDrugs2011-07-26 00:00:00Warning Letter192392
1000117586Cetero Research / Ba ResearchTexasUnited StatesDrugs2011-07-26 00:00:00Warning Letter194894
3006746551Big Rehab Corp.FloridaUnited StatesDevices2011-07-25 00:00:00Warning Letter183812
1000119368Electro Cap International IncOhioUnited StatesDevices2011-07-20 00:00:00Warning Letter187772
3000203342Archtek Dental, LLCIndianaUnited StatesDevices2011-07-20 00:00:00Warning Letter204392
3008480759Linda D. BossermanCaliforniaUnited StatesDrugs2011-07-19 00:00:00Warning Letter190013
3008572709Labcorp- PMDCaliforniaUnited StatesDevices2011-07-18 00:00:00Warning Letter188133
3003851100Genus Lifesciences Inc.PennsylvaniaUnited StatesDrugs2011-07-15 00:00:00Warning Letter174813
3007196368Seattle Sperm Bank LLCWashingtonUnited StatesBiologics2011-07-15 00:00:00Warning Letter195594
3008734284H & S GMP Factory-ChinaDrugs2011-07-14 00:00:00Warning Letter174672
3006702880Shaping Beauty, Inc.PennsylvaniaUnited StatesDrugs2011-07-14 00:00:00Warning Letter174672
3004680543Przedsiebiorstwo Farmaceutyczne Jelfa SA-PolandDrugs2011-07-14 00:00:00Warning Letter186694
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3003434767Bausch & Lomb IncorporatedCaliforniaUnited StatesDrugs2011-07-13 00:00:00Warning Letter195152
2243990Peace Medical Inc.New JerseyUnited StatesDevices2011-07-12 00:00:00Warning Letter181412
3008353013Joseph B. Michelson, MdCaliforniaUnited StatesDrugs2011-07-06 00:00:00Warning Letter182132
2938651Mayer Laboratories, Inc.CaliforniaUnited StatesDevices2011-07-05 00:00:00Warning Letter167292
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3002477077Signal Medical CorporationMichiganUnited StatesDevices2011-06-30 00:00:00Warning Letter199932
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3002616700MICROspecialties, Inc.ConnecticutUnited StatesDevices2011-06-28 00:00:00Warning Letter193353
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3004167898Pro-Paks, LLCConnecticutUnited StatesDevices2011-06-24 00:00:00Warning Letter197313
1037905Wilson-Cook Medical Inc.North CarolinaUnited StatesDevices2011-06-24 00:00:00Warning Letter199172
3002984011ZYDUS LIFESCIENCES LIMITED-IndiaDrugs2011-06-21 00:00:00Warning Letter192132
3003356844Heraeus Kulzer GmbH-GermanyDevices2011-06-16 00:00:00Warning Letter184372
3003395204Biolife, LLCFloridaUnited StatesDevices2011-06-15 00:00:00Warning Letter142630
3002806753Seqirus Pty Ltd-AustraliaBiologics2011-06-15 00:00:00Warning Letter189172
3007136419Advanced Fertility Group, PCIndianaUnited StatesBiologics2011-06-14 00:00:00Warning Letter186412
3004086182Pointcare Technologies, Inc.MassachusettsUnited StatesDevices2011-06-14 00:00:00Warning Letter191652
2128643H & P Industries, Inc.WisconsinUnited StatesDrugs2011-06-13 00:00:00Injunction74
1177786Centra Health Inc IRBVirginiaUnited StatesDevices2011-06-13 00:00:00Warning Letter178832
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