Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistClinical Resolution Laboratory Inc., a drug manufacturer in Brea, California, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered their finished pharmaceutical products adulterated. During an April 2021 inspection, the FDA found that the company failed to establish adequate written procedures for production and process control and could not provide data demonstrating that their over-the-counter drug manufacturing processes had been validated. Additionally, certain products were identified as unapproved new drugs and misbranded. The company's May 2021 response to the inspection findings was determined inadequate due to insufficient detail and evidence of corrective actions necessary to achieve compliance.