FDA 483 - Cosmecca Korea Co., Ltd. - September 13, 2024
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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.
ID · 38a9314c-b868-4c79-ae1d-42351a773034