Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistClean Cosmetics LLC, a drug manufacturer in Moorpark, California, was cited for significant current good manufacturing practice (CGMP) violations that resulted in adulterated finished pharmaceutical products. The company failed to conduct identity testing on incoming drug components and instead accepted supplier certificates of analysis without performing its own verification or validating the reliability of suppliers' test analyses at appropriate intervals, in violation of 21 CFR 211.84(d). The FDA found the company's September 2022 response to inspection findings inadequate, as it lacked sufficient detail and evidence of corrective actions needed to achieve compliance.