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