# FDA 483 - Merck Sharp & Dohme LLC - May 20, 2026

Source: https://www.keypedia.com/records/483/merck-sharp-dohme-llc/342bf1e5-c4a4-4faa-8191-9cf825958475

> FDA 483 for Merck Sharp & Dohme LLC on May 20, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Sharp & Dohme LLC
- Inspection Date: 2026-05-20
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: 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.

## Related Documents

- [EIR - 2018-10-30](https://www.keypedia.com/records/eir/merck-sharp-dohme-llc/9ab22e50-c9bc-4223-aa65-7be53e2d1d8d)
- [483 - 2021-04-16](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/8eeb13af-941d-45fe-be1d-581c3e337c75)
- [EIR - 2021-04-16](https://www.keypedia.com/records/eir/merck-sharp-dohme-llc/92501760-1393-44ea-8dc5-32fa013e2df2)

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/lizaida-perez/686fbdca-bfd7-4a73-990a-d8a97e6b88b7)
- [Investigator](https://www.keypedia.com/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

Company: https://www.keypedia.com/companies/merck-sharp-dohme-llc/967df80c-3ba2-42c7-918c-af2c89dc721c

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