FDA 483 - Merck Sharp & Dohme LLC - June 28, 2019

Merck Sharp & Dohme Corp. in Elkton, VA, was cited for two observations during an FDA inspection. The firm failed to adequately separate penicillin manufacturing operations from other drug products and lacked sufficient monitoring for beta-lactam contamination. Additionally, the company did not thoroughly investigate unexplained discrepancies or assess the effectiveness of corrective actions related to antibiotic containment.