# FDA 483 - Anhui Poly Pharm. Co., Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/anhui-poly-pharm-co-ltd/d6aba72c-b67b-4ff1-8f2e-643d2a2329a7

> FDA 483 for Anhui Poly Pharm. Co., Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Anhui Poly Pharm. Co., Ltd.
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: 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.

## Related Officers

- [Josh Renzo N. Ramilo](https://www.keypedia.com/people/josh-renzo-n-ramilo/5b0850ba-e22a-42fc-9310-2beeb921f8f6)

Company: https://www.keypedia.com/companies/anhui-poly-pharm-co-ltd/e1d9c61f-37b4-4759-8c00-51c6d0b78d3b

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3