FDA 483 - Mehrdad Kevin Ariani, MD - October 04, 2019

Mehrdad Kevin Ariani, MD, a clinical investigator in Northridge, CA, was inspected by the FDA from 9/30/2019 to 10/4/2019. The inspection revealed significant deviations from the investigational plan and protocol, including enrolling subjects who did not meet inclusion criteria and failing to report a serious adverse event to the CRO within the required timeframe. These findings indicate a failure to conduct investigations in accordance with established protocols.