# FDA 483 - CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd - November 11, 2025

Source: https://www.keypedia.com/records/483/cspc-zhongnuo-pharmaceutical-shijiazhuang-co-ltd/cb3c576d-a3b4-4b2b-b946-44625f6abff5

> FDA 483 for CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd on November 11, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd
- Inspection Date: 2025-11-11
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd, a manufacturer of sterile drug products, was cited for significant deficiencies during an FDA inspection. Observations included inadequate validation of aseptic processes, insufficient cleaning and disinfection protocols, and failures in environmental monitoring. Additionally, the firm was found to have poor documentation practices for production and process control procedures.

## 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/cspc-zhongnuo-pharmaceutical-shijiazhuang-co-ltd/31185e73-51d7-4117-8ef0-21b223b24d67

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