Mark Fleming, MD – FDA EIR, May 3, 2017

An FDA inspection of Mark Fleming, MD, operating within Virginia Oncology Associates, was conducted from April 26 to May 3, 2017. The inspection, initiated due to a serious non-compliance report from an Institutional Review Board (IRB), focused on Protocol GU14-182. The primary violation identified was Dr. Fleming's failure to conduct the study according to the investigational plan, specifically related to patient safety. A critical issue involved a subject (182-0014) who, despite experiencing elevated AST and ALT results requiring discontinuation from the study, was administered additional doses of the investigational drug. In one instance, the subject received study drug without confirmation of pre-administration lab results, which were critically elevated, and subsequently died. The IRB indicated this action likely contributed to the subject’s death. This conduct violated regulatory requirements for clinical investigators, including 21 CFR 312.60. At the close of the inspection, an FDA-483 was issued. Dr. Fleming acknowledged the observations and committed to implementing corrective actions, including new procedures and re-training, and submitted a written response to the FDA.