FDA 483 - Merck Sharp & Dohme LLC - August 23, 2024

An FDA inspection of Merck Sharp & Dohme LLC in West Point, PA, revealed significant deficiencies across three observations. The firm failed to thoroughly investigate various discrepancies, including foreign material contamination and numerous HEPA filter failures, and lacked adequate procedures to prevent microbiological contamination of sterile drug products. Additionally, equipment cleaning and maintenance practices were found to be insufficient, potentially impacting the quality and purity of several biological drug products.