# FDA 483 - Garen Koloyan, M.D., PhD. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/garen-koloyan-md-phd/0c15f5a3-c32b-4f70-a5ed-af382bb0b7ec

> FDA 483 for Garen Koloyan, M.D., PhD. on Unknown Date. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Garen Koloyan, M.D., PhD.
- Product Type: other
- Office Name: International Compliance Team
- Summary: An FDA inspection of Garen Koloyan, M.D., Ph.D. in Yerevan, Armenia, a clinical investigator for the "Mesh Suture" trial, revealed significant deviations from Good Clinical Practices. Findings included failures in subject enrollment, inconsistent and unattributable study data, inadequate device accountability, and a lack of ethics committee approval and informed consent documentation. These issues indicate serious deficiencies in the conduct and oversight of the clinical trial.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/lori-gioia/34b9339b-0bd2-4e41-8da1-b445ad829e53)
- [investigator](https://www.globalkeysolutions.net/people/colleen-e-burke/e013131b-6c14-4a60-b3ab-d8759d38624b)

Company: https://www.globalkeysolutions.net/companies/garen-koloyan-md-phd/6a533aa5-6327-4e46-8474-b7e54c77e511

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321