Merck Sharp & Dohme LLCSeptember 12, 2025

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

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Record Details

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.

Company: Merck Sharp & Dohme LLC
Inspection Date: September 12, 2025
Product Type: Drugs
Office: Atlanta District Office
People: Mabany Lizardi
Megan T. Ziegler ( CSO)
Santos E. Camara

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ID · f3615ac5-6f89-47ae-a2e5-c4c8c0e2a4b3