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
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-02
Compounding Pharmacy/Adulterated Drug Products
PQ Pharmacy, LLC
- 2025-12-02
Compounding Pharmacy/Adulterated Drug Products
Turbare Manufacturing
- 2025-12-02
CGMP/Finished Pharmaceuticals/Adulterated
Rhyz Analytical Labs
- 2025-11-25
Compounding Pharmacy/Adulterated Drug Products
Wells Pharma of Houston, LLC
- 2025-11-18
Nonprescription/OTC
DermaRite Industries, LLC
- 2025-11-04
CGMP/Finished Pharmaceuticals/Adulterated
Liebel-Flarsheim Company LLC
- 2025-11-04
CGMP/Finished Pharmaceuticals/Adulterated
Apotex Inc.
- 2025-10-07
CGMP/Finished Pharmaceuticals/Adulterated
Naturich Cosmetique Labs
Related Guidelines (10)
Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry (Status: Final)
→CPG Sec. 490.200 Parametric Release of Parenteral Drug Products Terminally Sterilized by Moist Heat (Status: Final)
→Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (Status: Final)
→Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision: Guidance for Industry (Status: Final)
→Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff (Status: Final)
→Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry (Status: Draft)
→Field Alert Report Submission: Questions and Answers Guidance for Industry: Guidance for Industry (Status: Final)
→Biological Product Deviation Reporting for Blood and Plasma Establishments: Guidance for Industry (Status: Final)
→Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry (Status: Draft)
→Data Integrity and Compliance With Drug CGMP: Questions and Answers: Guidance for Industry (Status: Final)
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