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Division of Pharmaceutical Quality Operations II

32 FDA 510(k) clearances · Issuing office

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◉ Watch Division of Pharmaceutical Quality Operations II

RecordFirmDate
Little Moon Essentials, LLC - FDA Warning Letter (2024-09-17)2024-09-17
Wittman Pharma, Inc. - FDA Warning Letter (2024-08-06)2024-08-06
Cosmetic Solutions, LLC - FDA Warning Letter (2024-05-31)2024-05-31
Sani-Care Salon Products, Inc. - FDA Warning Letter (2024-04-24)2024-04-24
Seatex, LLC - FDA Warning Letter (2024-04-01)2024-04-01
Seatex, LLC - FDA Warning Letter (2024-04-01)2024-04-01
Master Paints & Chemicals Corp. - FDA Warning Letter (2024-03-13)2024-03-13
Cosmetic Specialty Labs, Inc. - FDA Warning Letter (2024-02-29)2024-02-29
Colgin, Inc. - FDA Warning Letter (2024-01-25)2024-01-25
Dextrum Laboratories Inc. - FDA Warning Letter (2023-12-07)2023-12-07
Kor-Chem, Inc. - FDA Warning Letter (2023-09-11)2023-09-11
Lex Inc. - FDA Warning Letter (2023-08-17)2023-08-17
Gadal Laboratories Inc. - FDA Warning Letter (2023-08-15)2023-08-15
Iso-Tex Diagnostics, Inc. - FDA Warning Letter (2023-07-20)2023-07-20
Pharmacy Plus, Inc., dba Vital Care Compounder - FDA Warning Letter (2023-06-06)2023-06-06
Carolina Infusion - FDA Warning Letter (2023-05-22)2023-05-22
iSlim, LLC - FDA Warning Letter (2023-05-03)2023-05-03
Belmar Pharma Solutions, Drug Depot, LLC., dba APS Pharmacy - FDA Warning Letter (2023-03-31)2023-03-31
Dunagin Pharmaceuticals Inc. dba Massco Dental - FDA Warning Letter (2023-02-22)2023-02-22
Gascó Industrial Corporation - FDA Warning Letter (2023-02-17)2023-02-17
Midlab Incorporated - FDA Warning Letter (2023-02-15)2023-02-15
Frenda Corporation - FDA Warning Letter (2023-02-15)2023-02-15
Profounda, Inc. - FDA Warning Letter (2023-02-01)2023-02-01
Skyless, LLC - FDA Warning Letter (2023-01-23)2023-01-23
Mohawk Laboratories Division of NCH Corporation - FDA Warning Letter (2023-01-18)2023-01-18
Salon Technologies International, Inc. - FDA Warning Letter (2022-12-21)2022-12-21
Auto-Chlor System LLC - FDA Warning Letter (2022-12-20)2022-12-20
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding - FDA Warning Letter (2022-11-18)2022-11-18
Omega & Delta Co., Inc. - FDA Warning Letter (2022-11-02)2022-11-02
NatureLab Corp. - FDA Warning Letter (2022-07-12)2022-07-12
Frozen Wheels, LLC - FDA Warning Letter (2021-12-20)2021-12-20
Allay Pharmaceuticals, LLC - FDA Warning Letter (2021-01-27)2021-01-27

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Every clearance here is in the API, with alerts when new ones post.