FDA 483 - Zhejiang Tianyu Pharmaceutical Co. Ltd. - November 21, 2024

An FDA inspection of Zhejiang Tianyu Pharmaceutical Co., Ltd. in Huangyan, China, an API manufacturer, revealed significant deficiencies in quality control and equipment cleaning. The firm failed to establish proper impurity profiles for identified and unidentified impurities in recovered materials and intermediates, and also lacked appropriate cleaning schedules for storage tanks, leading to potential contamination risks. These issues indicate a lack of robust quality systems for API manufacturing.