# FDA 483 - Zhejiang Haisen Pharmaceutical Co., Ltd. - April 11, 2018

Source: https://www.globalkeysolutions.net/records/483/zhejiang-haisen-pharmaceutical-co-ltd/b0f2eebb-c102-4599-9f9a-419e15fab306

> FDA 483 for Zhejiang Haisen Pharmaceutical Co., Ltd. on April 11, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Haisen Pharmaceutical Co., Ltd.
- Inspection Date: 2018-04-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Zhejiang Haisen Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredient manufacturer, was cited for two significant observations during an FDA inspection. The firm demonstrated issues with data integrity, specifically inconsistencies between validation reports and raw data, and a lack of authenticity review for submitted data. Additionally, the company failed to adequately record, document, and investigate customer complaints in a timely manner, indicating deficiencies in their quality system.

## Related Officers

- [Consumer Safety Officer at Commissioned Corps of the U.S. Public Health Service](https://www.globalkeysolutions.net/people/latorie-s-jones/086d0897-7d63-4fa8-bdce-f1d17885abd7)

Company: https://www.globalkeysolutions.net/companies/zhejiang-haisen-pharmaceutical-co-ltd/2d2c27d1-770f-4367-a180-92298e925ab8

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