Merck Sharp & Dohme LLCAugust 24, 2012

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

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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.

Company: Merck Sharp & Dohme LLC
Inspection Date: August 24, 2012
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East II
People: Nebil Al Oumer (Director of Medical and Pharmaceutical Operations)
Brooke K. Higgins

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