# FDA 483 - Merck Sharp & Dohme LLC - August 24, 2012

Source: https://www.keypedia.com/records/483/merck-sharp-dohme-llc/6d963232-5fe6-44e9-8a6f-324e61081611

> FDA 483 for Merck Sharp & Dohme LLC on August 24, 2012. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Sharp & Dohme LLC
- Inspection Date: 2012-08-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Merck Sharp & Dohme Corp. in Elkton, VA, an API and finished dosage pharmaceutical manufacturer, revealed two significant observations. The firm failed to thoroughly investigate unexplained discrepancies related to sterility assurance for Primaxin lots. Additionally, deficiencies were noted in aseptic processing areas concerning air supply and incomplete airflow pattern studies.

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## Related Officers

- [Director of Medical and Pharmaceutical Operations](https://www.keypedia.com/people/nebil-al-oumer/7384a076-de9c-4b64-95cd-1c79c3c7d829)
- [Brooke K. Higgins](https://www.keypedia.com/people/brooke-k-higgins/d3d34a14-68db-4233-bc1f-876895cd211b)

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