# Merck Sharp & Dohme LLC – FDA 483, Aug 23, 2024

Source: https://www.keypedia.com/records/483/merck-sharp-dohme-llc/1dea200c-704e-401b-9776-f1543cb04387

> FDA 483 for Merck Sharp & Dohme LLC on August 23, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Sharp & Dohme LLC
- Inspection Date: 2024-08-23
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Merck Sharp & Dohme LLC in West Point, PA, revealed significant deficiencies across three observations. The firm failed to thoroughly investigate various discrepancies, including foreign material contamination and numerous HEPA filter failures, and lacked adequate procedures to prevent microbiological contamination of sterile drug products. Additionally, equipment cleaning and maintenance practices were found to be insufficient, potentially impacting the quality and purity of several biological drug products.

## Related Documents

- [EIR - 2019-09-20](https://www.keypedia.com/records/eir/merck-sharp-dohme-llc/8e34a33b-4b77-46e3-a555-3cb77cdf99cf) — date: September 20, 2019
- [483 - 2019-09-09](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/4991dc98-f2fb-404a-997c-26727b72fb45) — date: September 9, 2019
- [483 - 2019-04-30](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/d805733b-38ac-429b-acd8-52ebec9a0770) — date: April 30, 2019
- 483 - 2015-04-17 — date: April 17, 2015
- [483](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/0f66a4fc-0947-4026-9ece-e2ba69104767)

## Related Officers

- [Olga Simakova](https://www.keypedia.com/people/olga-simakova/2ee5985e-425e-4732-8869-2be861f5d792)
- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)
- [Travis S. Bradley](https://www.keypedia.com/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)

Company: https://www.keypedia.com/companies/merck-sharp-dohme-llc/842c6e25-ee89-453c-a5b0-6b039c187744

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8