FDA 483 - Taizhou Kangping Medical Science And Technology Co., Ltd. - March 14, 2025

An FDA inspection of Taizhou Kangping Medical Science And Technology Co., Ltd., an OTC contract manufacturer in Taizhou, China, revealed significant data integrity issues and systemic failures in cGMP compliance. The firm exhibited deficiencies in laboratory record-keeping, stability programs, process validation, and computer system controls, including repeat observations. These findings indicate a lack of adequate oversight and control over critical manufacturing and quality processes, raising concerns about the quality and reliability of drug products.