Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistCohere Beauty's drug manufacturing facility failed to establish adequate written procedures and validate manufacturing processes for over-the-counter drug products, resulting in at least multiple lots being manufactured, released, and distributed in 2023 without proper process validation studies. The FDA inspection in November 2023 found significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR 211.100(a), rendering the drug products adulterated because the company could not demonstrate that manufacturing processes were controlled to consistently yield products of uniform character and quality. The company's response, which offered only a summary of release testing data rather than adequate assurance that previously distributed batches were safe and effective, was deemed inadequate by the FDA.