FDA 483 - Merck Sharp & Dohme LLC - May 20, 2026
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Merck Sharp & Dohme LLC in Durham, NC, a vaccine manufacturer, was cited for deficiencies in its equipment maintenance program and investigation procedures. The firm's lyophilization equipment experienced multiple critical process parameter excursions, indicating an ineffective maintenance program. Furthermore, the firm failed to thoroughly investigate these equipment malfunctions, continuing to use affected lyophilizers for manufacturing additional batches while investigations remained open.
ID · 342bf1e5-c4a4-4faa-8191-9cf825958475