FDA 483 - Asymchem Life Science (Tianjin) Co., Ltd. - March 21, 2025

An FDA inspection of Asymchem Life Science (Tianjin) Co., Ltd., a drug manufacturer, revealed significant deficiencies in quality control and data integrity. The firm failed to thoroughly review manufacturing discrepancies, maintain written procedures for its quality control unit, and implement adequate controls over computer systems for data backup. These issues indicate a lack of robust oversight in critical manufacturing and data management processes.