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Talk to a SpecialistTalk to a SpecialistPersōn & Covey, Inc., a drug manufacturer in Glendale, California, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated. Specific violations included failure of the quality control unit to adequately document and investigate out-of-specification results, inadequate manufacturing controls and processes, and introduction of unapproved new drugs (Xerac AC and Drysol) into interstate commerce. The company's February 2025 response to FDA's inspection findings was deemed inadequate due to lack of supporting documentation and insufficient evidence of corrective actions to achieve compliance.