483
PMS4PMSPMS4PMS – FDA 483, Nov 8, 2024
Record Details
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.
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ID · 9a695258-6d59-4153-948e-ceabe634a733
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