# Zhejiang Anglikang Pharmaceutical Co., Ltd. – FDA 483, Nov 21, 2025

Source: https://www.keypedia.com/records/483/zhejiang-anglikang-pharmaceutical-co-ltd/9e04c03c-b851-4df5-b361-660744381190

> FDA 483 for Zhejiang Anglikang Pharmaceutical Co., Ltd. on November 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Anglikang Pharmaceutical Co., Ltd.
- Inspection Date: 2025-11-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Zhejiang Anglikang Pharmaceutical Co., Ltd. in Shaoxing, China, was inspected regarding its sterile drug product manufacturing. The inspection revealed significant deficiencies across aseptic processing, environmental monitoring, batch recordkeeping, laboratory controls, and component management. These issues indicate a high risk of microbiological contamination and data integrity concerns, impacting the quality and sterility assurance of drug products intended for the US market.

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [WenNing Chan](https://www.keypedia.com/people/wenning-chan/973bf578-405d-46cf-b09e-254d6db07c08)

Company: https://www.keypedia.com/companies/zhejiang-anglikang-pharmaceutical-co-ltd/d4002d6c-9d1a-48f6-81a1-41b04d25fff9

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8