FDA 483 - Hankook Cosmetics Manufacturing Co., Ltd - November 21, 2024

Hankook Cosmetics Manufacturing Co., Ltd, an OTC drug product manufacturer in Eumseong-gun, Korea, was cited for significant deficiencies in its quality control, laboratory practices, and equipment maintenance. The inspection revealed failures in stability testing, incomplete laboratory records, lack of written procedures for critical quality unit responsibilities, inadequate sampling plans, and insufficient cleaning and maintenance procedures for manufacturing equipment. These issues indicate a systemic lack of adherence to good manufacturing practices.