FDA 483 - Zhejiang Cheng Yi Pharmaceutical Co., Ltd. - November 22, 2019

An FDA inspection of Zhejiang Cheng Yi Pharmaceutical Co., Ltd in Wenzhou, China, revealed significant deficiencies across its quality, production, and laboratory systems. The firm failed to ensure proper quality control unit authority, maintain adequate written procedures, validate manufacturing processes, and store drug product standards under appropriate conditions. These issues indicate a lack of adherence to good manufacturing practices.