FDA 483 - Hanacos Co., Ltd. - November 30, 2023

Hanacos Co., Ltd., an OTC drug product manufacturer in Hoengseong, Korea, was cited for multiple significant deficiencies during an FDA inspection. The firm's quality system was found to be severely lacking, with repeat observations concerning stability programs, employee training, annual product reviews, cleaning validation, and equipment qualification. Additionally, the firm failed to perform critical microbial testing and validate its test methods according to U.S. cGMP regulations.