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

Source: https://www.keypedia.com/records/483/merck-sharp-dohme-llc/f3615ac5-6f89-47ae-a2e5-c4c8c0e2a4b3

> FDA 483 for Merck Sharp & Dohme LLC on September 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Sharp & Dohme LLC
- Inspection Date: 2025-09-12
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: 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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Company: https://www.keypedia.com/companies/merck-sharp-dohme-llc/e0f09e1e-dc3b-4398-98ea-0a4e8a94b398

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7