FDA 483 - Mark Fleming, MD - May 03, 2017

An FDA Form 483 was issued to Mark Fleming, MD, a clinical investigator in Norfolk, VA, following an inspection from April 26 to May 3, 2017. The inspection revealed a significant deviation from an investigational plan. Specifically, a study subject with elevated liver enzymes was not discontinued from the study as required by the protocol, and was subsequently dosed with the study drug.