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

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.