Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistGeneritech Corporation, a drug manufacturer in Fresno, California, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of finished pharmaceutical products, including topical OTC drugs and unapproved new drugs such as Hydroquinone Cream. During a July 2021 inspection, the FDA identified failures to thoroughly investigate out-of-specification (OOS) assay results for multiple drug lots and inadequate batch discrepancy investigations, rendering the products adulterated. The company's September 2021 response to the FDA's Form 483 was deemed insufficient as it lacked adequate detail and evidence of corrective actions necessary to achieve compliance with CGMP regulations.