Merck Sharp & Dohme LLCJune 28, 2019

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

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Record Details

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.

Company: Merck Sharp & Dohme LLC
Inspection Date: June 28, 2019
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East II
Person: David A. Oluwo (Pharmacy Intern/Certified Pharmacy Technician)

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ID · a1b0b574-3400-4884-9b75-efdd7f3d8a7e