483
Anhui Poly Pharm. Co., Ltd.Anhui Poly Pharm. Co., Ltd. – FDA 483
Record Details
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
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ID · d6aba72c-b67b-4ff1-8f2e-643d2a2329a7
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