Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistCosmetic Manufacturers Pty Ltd. received a warning letter for manufacturing adulterated drug products in violation of Current Good Manufacturing Practice (CGMP) regulations. During an inspection of their Australian facility in March-April 2025, the FDA identified critical failures in batch release testing, including the company's failure to conduct required laboratory testing for identity, strength, and preservative content of active ingredients prior to product release, as required by 21 CFR 211.165(a). The company's response was deemed inadequate, as it only committed to validating future test methods and conducting retrospective testing rather than comprehensively reevaluating batch release criteria to ensure all drug products met critical quality attributes.