FDA 483 - Seoul Cosmetics Co., Ltd. - February 03, 2023

Seoul Cosmetics Co., Ltd. in Namdong, Incheon, Korea, a drug manufacturer, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant deficiencies across quality systems, facilities and equipment, laboratory controls, production, and materials systems. Key issues included a lack of process validation, inadequate stability data, unvalidated equipment, deficient test methods with data integrity concerns, and insufficient raw material and in-process testing.