FDA 483 - Merck Sharp & Dohme LLC - November 19, 2015

Merck Sharp & Dohme in Rahway, NJ, was cited for significant deficiencies in its conduct and oversight of clinical investigations, specifically Protocol No. P04103. The inspection revealed failures in reporting critical safety and effectiveness data, ensuring adherence to investigational plans, and proper study monitoring. These issues indicate a lack of robust controls over clinical trial data integrity and regulatory reporting.