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Office of Pharmaceutical Quality Operations, Division II

25 FDA 510(k) clearances · Issuing office

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RecordFirmDate
Max Chemical Inc. - FDA Warning Letter (2024-06-20)2024-06-20
ARG Laboratories, Inc. - FDA Warning Letter (2024-06-11)2024-06-11
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC - FDA Warning Letter (2022-10-21)2022-10-21
Nephron SC Inc. - FDA Warning Letter (2022-10-11)2022-10-11
Sovereign Pharmaceuticals, LLC - FDA Warning Letter (2022-10-05)2022-10-05
Sanitizer Supply LLC - FDA Warning Letter (2022-09-02)2022-09-02
Vita Pharmacy, LLC dba Talon Pharmacy of Boerne - FDA Warning Letter (2022-08-29)2022-08-29
Monarch PCM, LLC - FDA Warning Letter (2022-06-10)2022-06-10
Hybrid Pharma, LLC - FDA Warning Letter (2022-06-07)2022-06-07
Froggy’s Fog LLC - FDA Warning Letter (2022-04-14)2022-04-14
Agropharma Laboratories, Inc. - FDA Warning Letter (2022-03-25)2022-03-25
Med Shop Total Care, Inc. - FDA Warning Letter (2022-03-18)2022-03-18
Innoveix Pharmaceuticals Inc - FDA Warning Letter (2022-01-26)2022-01-26
Empower Clinic Services, LLC dba Empower Pharmacy - FDA Warning Letter (2021-10-15)2021-10-15
Sircle Laboratories, LLC - FDA Warning Letter (2021-09-21)2021-09-21
Apothecary Health Solutions/Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop - FDA Warning Letter (2021-09-20)2021-09-20
Walfer Corporation dba The Medicine Shoppe Pharmacy - FDA Warning Letter (2021-09-17)2021-09-17
Genesis Nutrition Ultra Slim dba Genesis Ultra Slim - FDA Warning Letter (2021-08-06)2021-08-06
Maitland Labs of Central Florida - FDA Warning Letter (2021-08-06)2021-08-06
Farmakeio Outsourcing LLC - FDA Warning Letter (2021-07-29)2021-07-29
Sanit Technologies, LLC dba Durisan - FDA Warning Letter (2021-07-27)2021-07-27
Matthew 7:25 Inc dba Thrive Pharmacy - FDA Warning Letter (2021-07-22)2021-07-22
Exela Pharma Sciences LLC - FDA Warning Letter (2021-04-08)2021-04-08
American Specialty Pharmacy, Inc. dba ASP Cares - FDA Warning Letter (2021-04-05)2021-04-05
Maison Terre, LLC - FDA Warning Letter (2021-04-01)2021-04-01

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