FDA 483 - Jiangsu Baozong & Baoda Pharmachem Co., Ltd. - March 28, 2025

An FDA inspection of Jiangsu Baozong & Baoda Pharmachem Co., Ltd. in Nantong, China, revealed significant deficiencies in the manufacturing of Active Pharmaceutical Ingredients for Veterinary Use. Observations included inadequate control and documentation of production equipment, lack of proper cleaning and storage, and insufficient laboratory testing for API release and stability. These issues indicate a serious lack of quality control and good manufacturing practices.