FDA 483 - Merck Sharp & Dohme LLC

Merck Sharp & Dohme Corp. in Elkton, VA, a bulk vaccine manufacturer, was cited for six observations during an FDA inspection. The inspection revealed significant issues including inadequate investigations into discrepancies and contamination, insufficient controls to prevent cross-contamination from personnel movement, and poor management of documents and electronic data. Additionally, the firm failed to follow document review procedures and lacked proper monitoring and trending for facilities and equipment.