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483
•Merck & Company•January 20, 2021

FDA 483 - Merck & Company - January 20, 2021

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Record Details

An FDA inspection of Merck & Company in Rahway, NJ, identified a failure to ensure proper monitoring of a clinical study. Specifically, the firm did not submit monitoring follow-up letters with visit reports within the required timeframe as stipulated in their own Clinical Monitoring Plan. This indicates a procedural lapse in clinical trial oversight.

Company
Merck & Company
Inspection Date
January 20, 2021
Product Type
Drugs
Office
New Jersey District Office
Person
  • Nina Yang (investigator)
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ID · 8fe7da63-81b9-4bc2-b4b0-bdfc3a1fbe5c

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