FDA 483 - Taizhou Kangping Medical Science And Technology Co., Ltd. - March 07, 2019

An FDA inspection of Taizhou Kangping Medical Science and Technology Co., Ltd., an OTC drug manufacturer in Taizhou City, Jiangsu, China, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly investigate out-of-specification results, did not use unique lot numbers for drug products, and maintained deficient master production and control records. These issues indicate a lack of adequate controls to ensure product quality and traceability.