# FDA 483 - Merck & Company - January 20, 2021

Source: https://www.globalkeysolutions.net/records/483/merck-company/8fe7da63-81b9-4bc2-b4b0-bdfc3a1fbe5c

> FDA 483 for Merck & Company on January 20, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck & Company
- Inspection Date: 2021-01-20
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/nina-yang/8d080437-2e05-4b75-8c53-b818d761cf1f)

Company: https://www.globalkeysolutions.net/companies/merck-company/510c76fe-2021-4989-895c-c11747b17be9

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248