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

The FDA issued a Warning Letter to Taizhou Kangping Medical Science and Technology Co., Ltd. following an inspection from March 10-14, 2025, revealing significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). Consequently, their drug products are deemed adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. Key issues observed include the failure to establish procedures preventing micro-contamination for products labeled as sterile, which were neither sterilized nor subjected to sterility testing. The company also failed to implement appropriate product specifications and scientifically sound testing procedures, specifically noting inadequate system suitability for analytical testing and critical data integrity lapses. These lapses involved uncontrolled data acquisition systems, shared access to analytical equipment, deletion of records, and the use of unvalidated spreadsheets for product release. Furthermore, certain products had active ingredient concentrations significantly exceeding allowable limits under Section 505G of the FD&C Act. Taizhou Kangping has initiated a recall of affected products. The FDA requires a comprehensive investigation into data inaccuracies, a thorough risk assessment of quality failures, and a detailed management strategy with a global corrective and preventive action plan to ensure data reliability and overall product quality.