FDA 483 - Merck Sharp & Dohme LLC - September 12, 2025

Merck Sharp & Dohme LLC in Wilson, NC, received a Form 483 with six observations during an inspection from September 5-12, 2025. The observations highlight significant deficiencies in equipment maintenance, contamination control, microbiological quality systems, data integrity, and quality unit oversight. These issues collectively indicate a lack of adequate controls to prevent drug product contamination, ensure data reliability, and maintain product quality.