# FDA 483 - Amarex Clinical Research, LLC - December 29, 2021

Source: https://www.globalkeysolutions.net/records/483/amarex-clinical-research-llc/b91ae07d-9a97-463a-9ca0-968328c6ad61

> FDA 483 for Amarex Clinical Research, LLC on December 29, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amarex Clinical Research, LLC
- Inspection Date: 2021-12-29
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Amarex Clinical Research, LLC, a Contract Research Organization in Germantown, MD, revealed significant deficiencies in clinical study monitoring. The firm failed to ensure proper oversight of studies, including the absence of a required Data Monitoring Committee for one study. Additionally, numerous on-site and remote monitoring visits were not conducted as scheduled, and many monitoring reports were finalized well beyond the required timeframe.

## Related Officers

- [Consumer Safety Officer/BIMO Investigator](https://www.globalkeysolutions.net/people/david-l-chon/227b9c21-14c4-442b-bdc3-ad167567fd92)

Company: https://www.globalkeysolutions.net/companies/amarex-clinical-research-llc/1fe4c07b-4ea1-4b76-821c-c20a7e0bfad4

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64