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

An FDA inspection of Hankook Cosmetics Manufacturing Co., Ltd in Eumseong-gun, Korea, an OTC drug product manufacturer, revealed significant deficiencies in their quality systems. Observations included a lack of completed stability studies to support expiration dates, incomplete laboratory records, and inadequate written procedures for quality control, sampling, and equipment cleaning. These findings indicate a broad failure to adhere to good manufacturing practices.