FDA 483 - Person & Covey Inc - February 06, 2025

Person & Covey Inc, a manufacturer in Glendale, CA, was cited for significant deficiencies across its quality control, production, and laboratory operations during an FDA inspection. The firm failed to thoroughly investigate discrepancies, lacked an effective quality control unit, and did not maintain adequate written procedures for manufacturing processes or a proper stability program. Additionally, issues with record retention, data integrity in laboratory systems, and the absence of active ingredient reserve samples were noted, indicating a broad lack of adherence to cGMP regulations.