Merck & Co. Inc – FDA 483, Aug 26, 2016

Merck Sharp & Dohme received a Form FDA 483 for significant deficiencies in clinical study oversight and investigator management. The firm failed to ensure proper monitoring, including verifying source documents and overseeing subcontracted organizations. Additionally, Merck did not promptly address or terminate non-compliant investigators and failed to notify the FDA of such terminations.