FDA 483 - Garen Koloyan, M.D., PhD.

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.