# FDA 483 - Zhejiang Huahai Pharmaceutical Co., Ltd. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/zhejiang-huahai-pharmaceutical-co-ltd/73de650e-42cd-44dd-938a-9db63bd2aa36

> FDA 483 for Zhejiang Huahai Pharmaceutical Co., Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Huahai Pharmaceutical Co., Ltd.
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Zhejiang Huahai Pharmaceutical Co., Ltd. in Linhai, China, revealed critical deficiencies across its drug manufacturing operations. The firm failed to maintain adequate cleaning procedures, validate aseptic processes, establish proper production controls, and ensure thorough investigations into product discrepancies. These widespread issues indicate a significant lack of control over manufacturing processes, posing risks to the quality and safety of drug products for the US market.

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## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Research Specialist II](https://www.globalkeysolutions.net/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.globalkeysolutions.net/companies/zhejiang-huahai-pharmaceutical-co-ltd/77f8f66f-ca2e-4b91-b460-a4bd2041c866

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