FDA 483 - Shanghai Co-Fun Biotech Corp., Ltd. - March 21, 2019

An FDA inspection of Shanghai Co-Fun Biotech Corporation, Ltd. in Shanghai, China, revealed severe and systemic data integrity issues, including widespread falsification of GMP documents. The firm's Quality Unit was found to have misled investigators, forged numerous records, and lacked effective oversight, indicating a profound failure to adhere to current Good Manufacturing Practices for Active Pharmaceutical Ingredients. This included falsified stability programs, process validation, laboratory testing data, and employee training records, often prepared and backdated just prior to the inspection.