Yangzhou Sion Commodity Co., Ltd. – 699183 – 03/12/2025
CGMP/Finished Pharmaceutical/API/Adulterated
Hangzhou Glamcos Biotech Co., Ltd. – 692583 – 10/07/2024
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Aspen Biopharma Labs Private Limited – 698665 – 03/05/2025
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
BPI Labs, LLC – 699533 – 03/20/2025
Unapproved New Drugs/Misbranded
Food and Drug Administration Amendments Act (FDAAA) of 2007
Food and Drug Administration Amendments Act (FDAAA) of 2007
Prescription Drug Marketing Act of 1987
FDA’s implementation of the Prescription Drug Marketing Act of 1987
Food and Drug Omnibus Reform Act (FDORA) of 2022
The Food and Drug Omnibus Reform Act of 2022 (FDORA) requires FDA to develop several different kinds of informational documents,…
GFA Production Xiamen Co., Ltd. – 678364 – 06/13/2024
CGMP/Finished Pharmaceuticals/Adulterated
Angela D. Ritter, M.D. – 681999 – 06/07/2024
Clinical Investigator (Sponsor)
Aqualex Co., Ltd. – 672292 – 06/12/2024
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Adulterated