# FDA 483 - Merck Sharp & Dohme LLC - Unknown Date

Source: https://www.keypedia.com/records/483/merck-sharp-dohme-llc/23fe963f-f437-4f25-981f-ad46c475a27c

> FDA 483 for Merck Sharp & Dohme LLC on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Sharp & Dohme LLC
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: Merck, Sharpe & Dohme Corp. was cited for numerous deficiencies across its manufacturing and laboratory operations. Key issues include inadequate sterility testing procedures, insufficient environmental monitoring, and failures in quality control investigations for batch rejections and product defects. The inspection revealed systemic problems in ensuring product quality, purity, and potency, particularly concerning vaccine manufacturing and aseptic processing.

## Related Documents

- [483 - 2019-04-30](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/d805733b-38ac-429b-acd8-52ebec9a0770)
- [483 - 2019-09-09](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/4991dc98-f2fb-404a-997c-26727b72fb45)
- [483 - Unknown Date](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/0f66a4fc-0947-4026-9ece-e2ba69104767)
- [483 - 2024-08-23](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/1dea200c-704e-401b-9776-f1543cb04387)

## Related Officers

- [Shuang Tang, Research Biologist](https://www.keypedia.com/people/shuang-tang-research-biologist/092f82be-f1d9-4c9d-a132-f1f653d47ead)
- [Cynthia Jim, Investigator](https://www.keypedia.com/people/cynthia-jim-investigator/2ec4e856-fe8a-41eb-8096-a39fde0ad107)
- [Simone Pitts, Investigator](https://www.keypedia.com/people/simone-pitts-investigator/76e306ff-399a-45a6-9fb1-9b0f147ae1a3)
- [Haruhiko Murata, Research Biologist](https://www.keypedia.com/people/haruhiko-murata-research-biologist/b4718072-2ab9-4cd2-abce-1f587da540f0)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1