FDA 483 - Chandan B. Mehta, MD - November 21, 2019

An FDA inspection of Chandan B. Mehta, M.D., Clinical Investigator in Detroit, MI, revealed significant deviations from the investigational plan and proper device control. Observations included failure to follow disease-specific inclusion criteria, lack of Institutional Review Board submission for protocol updates, and unauthorized use of an investigational device on a randomized subject. These issues indicate a lack of adherence to regulatory requirements for clinical investigations.