# FDA 483 - Zhejiang Huahai Pharmaceutical Co., Ltd. - May 31, 2019

Source: https://www.globalkeysolutions.net/records/483/zhejiang-huahai-pharmaceutical-co-ltd/30c96b5f-fed4-4761-bd29-7764a4ff72bf

> FDA 483 for Zhejiang Huahai Pharmaceutical Co., Ltd. on May 31, 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: 2019-05-31
- Product Type: drugs
- Office Name: Division of Human and Animal Food East V Compliance Branch
- Summary: This FDA Form 483 was issued to Zhejiang Huahai Pharmaceutical Co. Ltd. in Linhai, China, an API and drug product manufacturer, following an inspection from May 20-31, 2019. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate analytical method validation, a scientifically unsound cleaning validation program, and insufficient evaluation of the solvent recovery process. Additionally, the firm failed to adequately identify unknown peaks, initiate investigations into manufacturing deviations, and implement effective corrective and preventative actions for complaint investigations.

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-east-v-compliance-branch/00f6013b-7c92-4daf-ae51-d47ab44bf1cb