# FDA 483 - Zhejiang Huazhou Pharmaceutical Co., Ltd. - March 22, 2018

Source: https://www.keypedia.com/records/483/zhejiang-huazhou-pharmaceutical-co-ltd/36cebc8b-c0f7-4e5c-8a06-0a6efc7dcf2d

> FDA 483 for Zhejiang Huazhou Pharmaceutical Co., Ltd. on March 22, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Huazhou Pharmaceutical Co., Ltd.
- Inspection Date: 2018-03-22
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Zhejiang Huazhou Pharmaceutical Co Ltd, an API intermediate manufacturer in Jiaojiang District, P.R.C., was cited with eight observations during an FDA inspection. The inspection revealed significant issues across laboratory systems, production, facilities, and material control, including failures in OOS investigations, inaccurate logs, inadequate equipment controls, and improper material labeling. These findings indicate a lack of robust quality control and data integrity practices.

## Related Officers

- [Senior Director Technical](https://www.keypedia.com/people/christopher-t-middendorf/0fea23f5-ffe6-49a0-ac33-780317707c71)

Company: https://www.keypedia.com/companies/zhejiang-huazhou-pharmaceutical-co-ltd/39d25471-d977-4a86-b5f9-8d4feb8d19bb

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321