# FDA 483 - Zhejiang Shenzhou Pharmaceutical Co., Ltd. - September 12, 2025

Source: https://www.globalkeysolutions.net/records/483/zhejiang-shenzhou-pharmaceutical-co-ltd/e4c694ed-fca1-46ec-a63e-a469a4bdf305

> FDA 483 for Zhejiang Shenzhou Pharmaceutical Co., Ltd. on September 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Shenzhou Pharmaceutical Co., Ltd.
- Inspection Date: 2025-09-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Zhejiang Shenzhou Pharmaceutical Co. Ltd, a manufacturer of bulk drug substances in Taizhou, China, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate Out of Specification investigations, failure to microbiologically test water used in drug substance production, non-adherence to equipment cleaning procedures, and unestablished accuracy of critical test methods. These issues indicate a lack of robust quality control and potential risks to product quality.

## Related Officers

- [Patty P. Kaewsurasangkul](https://www.globalkeysolutions.net/people/patty-p-kaewsurasangkul/c8d08bef-24f5-4b21-8a41-fef6bddb2e44)

Company: https://www.globalkeysolutions.net/companies/zhejiang-shenzhou-pharmaceutical-co-ltd/ac1b3e0f-8224-4922-926d-acda762d7f75

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1