FDA 483 - Anhui Poly Pharm. Co., Ltd.
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Anhui Poly Pharm. Co., Ltd., an API manufacturer in Anqing, China, was inspected by the FDA from February 24 to February 27, 2025. The inspection revealed a significant issue with the firm's quality control unit failing to test in-process materials for quality after long storage periods. Specifically, the firm's bulk hold time studies for API products were found to be inadequate, lacking assessment of bulk intermediate API study samples before placing finished API on stability.
- Company
- Anhui Poly Pharm. Co., Ltd.
- Product Type
- Drugs
- Office
- Office of Partnerships
- Person
ID · d6aba72c-b67b-4ff1-8f2e-643d2a2329a7