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

Source: https://www.keypedia.com/records/483/merck-sharp-dohme-llc/cd3c6683-fa2c-4c1a-8573-acbaa0db50fa

> 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: Division of Human and Animal Food Operations - East II
- Summary: Merck Sharp & Dohme Corp. in Elkton, VA, a bulk vaccine manufacturer, was cited for six observations during an FDA inspection. The inspection revealed significant issues including inadequate investigations into discrepancies and contamination, insufficient controls to prevent cross-contamination from personnel movement, and poor management of documents and electronic data. Additionally, the firm failed to follow document review procedures and lacked proper monitoring and trending for facilities and equipment.

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## Related Officers

- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e