FDA 483 - PMS4PMS - November 08, 2024

PMS4PMS, an OTC manufacturer in Clarence, NY, was cited for significant deficiencies during an FDA inspection from November 4-8, 2024. The firm lacked a quality control unit and failed to implement essential CGMP-compliant quality systems for its Comforte' Menstrual Cramp Relief Cream. Key issues included inadequate product release testing, raw material testing, unsubstantiated expiration dating, and insufficient employee training.