# FDA 483 - Merck Sharp & Dohme LLC - June 28, 2019

Source: https://www.keypedia.com/records/483/merck-sharp-dohme-llc/a1b0b574-3400-4884-9b75-efdd7f3d8a7e

> FDA 483 for Merck Sharp & Dohme LLC on June 28, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Sharp & Dohme LLC
- Inspection Date: 2019-06-28
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Merck Sharp & Dohme Corp. in Elkton, VA, was cited for two observations during an FDA inspection. The firm failed to adequately separate penicillin manufacturing operations from other drug products and lacked sufficient monitoring for beta-lactam contamination. Additionally, the company did not thoroughly investigate unexplained discrepancies or assess the effectiveness of corrective actions related to antibiotic containment.

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## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

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