# FDA 483 - Merck Sharp & Dohme LLC - January 22, 2025

Source: https://www.keypedia.com/records/483/merck-sharp-dohme-llc/6b19a3a5-3b6a-4180-9e03-792afb6fd3fd

> FDA 483 for Merck Sharp & Dohme LLC on January 22, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Merck Sharp & Dohme LLC
- Inspection Date: 2025-01-22
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: An FDA inspection of Merck Sharpe & Dohme LLC in Elkton, VA, revealed six observations primarily concerning contamination control and quality system deficiencies in sterile drug manufacturing. The findings include inadequate investigations into persistent mold contamination, a lack of detailed written procedures for aseptic processes, and unvalidated cleaning and inspection methods. These issues indicate significant concerns regarding the firm's ability to assure the quality and purity of its sterile drug products.

## Related Documents

- [483 - 2012-08-24](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/6d963232-5fe6-44e9-8a6f-324e61081611)
- [483 - Unknown Date](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/cd3c6683-fa2c-4c1a-8573-acbaa0db50fa)
- [483 - 2019-06-28](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/a1b0b574-3400-4884-9b75-efdd7f3d8a7e)
- [483 - Unknown Date](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/a37a43f6-5ab5-4504-8891-7a0a2aba2aa9)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Investigator](https://www.keypedia.com/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

Company: https://www.keypedia.com/companies/merck-sharp-dohme-llc/a9539664-d21e-42b0-9b17-b399cf4873ef

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa