483
Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC – FDA 483, Sep 12, 2025
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.
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ID · f3615ac5-6f89-47ae-a2e5-c4c8c0e2a4b3
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