# FDA 483 - Zhejiang Huahai Pharmaceutical Co., Ltd. - June 28, 2019

Source: https://www.globalkeysolutions.net/records/483/zhejiang-huahai-pharmaceutical-co-ltd/90a0c6c6-2a30-43db-ab08-8293a7514d58

> FDA 483 for Zhejiang Huahai Pharmaceutical Co., Ltd. on June 28, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Huahai Pharmaceutical Co., Ltd.
- Inspection Date: 2019-06-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Zhejiang Huahai Pharmaceutical Co. Ltd. in Linhai, China, an API and drug product manufacturer, was cited for significant deficiencies in its quality systems. Observations included incomplete investigations into product discrepancies, inadequate procedures for preventing microbiological contamination in sterile products, and failures in its change control system. The firm also had deficient master production records and laboratory control specifications.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/jonathan-w-chapman/5b5134c3-71f9-4212-9429-4554d91e8aa9)

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