Zhejiang Haisen Pharmaceutical Co., Ltd.April 11, 2018

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

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Record Details

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.

Company: Zhejiang Haisen Pharmaceutical Co., Ltd.
Inspection Date: April 11, 2018
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Latorie S. Jones (Consumer Safety Officer at Commissioned Corps of the U.S. Public Health Service)

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ID · b0f2eebb-c102-4599-9f9a-419e15fab306