FDA 483 - Kent C. Shih, MD, PI - November 15, 2016

An FDA inspection of Kent C. Shih, MD, PI, a clinical investigator in Nashville, TN, revealed significant deviations from the investigational plan. The investigator failed to ensure subjects received protocol-required premedication within the specified timeframe and did not report all adverse events as mandated by the protocol. These findings indicate a failure to adhere to clinical trial protocols.