Regulation Text
Authority
21 U.S.C. 321,351,352,355,360b,360ddd,360ddd-1,371,374;42 U.S.C. 216,262,263a,264.
Related Warning Letters (10)
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 2025-11-18
CGMP/Finished Pharmaceuticals/Adulterated
World Perfumes Inc.
- 2025-11-04
CGMP/Finished Pharmaceuticals/Adulterated
Liebel-Flarsheim Company LLC
- 2025-10-21
CGMP/Finished Pharmaceuticals/Adulterated
BRS Analytical Services, LLC
- 2025-06-03
CGMP/Finished Pharmaceuticals/Adulterated
Yiling Pharmaceutical Ltd.
- 2024-06-18
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Adulterated
Aqualex Co., Ltd.
- 2023-10-16
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Sun Pharmaceutical Industries Ltd.
- 2023-08-01
CGMP/Finished Pharmaceuticals/Adulterated
Baxter Healthcare Corporation
- 2023-03-14
CGMP/Finished Pharmaceuticals/Adulterated
Profounda, Inc.
- 2022-06-28
CGMP/Finished Pharmaceuticals/Adulterated
Monarch PCM, LLC
Related Guidelines (4)
Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry (Status: Final)
→Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (Status: Final)
→Process Validation: General Principles and Practices: Guidance for Industry (Status: Final)
→Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: Draft Guidance for Industry (Status: Draft)
→