FDA 483 - Cosmecca Korea Co., Ltd. - September 13, 2024

An FDA inspection of Cosmecca Korea Co Ltd in Eumseong-gun, Chungcheongbuk-do, revealed ten significant observations regarding their drug product manufacturing operations. Key deficiencies included inadequate laboratory controls, insufficient computer system validation, unverified testing methods, and incomplete record-keeping. The firm also failed in supplier qualification, proper component sampling, process validation, and quality unit oversight, with several issues being repeat observations from a prior 2017 inspection.