FDA 483 - Dr. James A. Thompson, M.D. - September 27, 2023

An FDA inspection of Inova Health System, specifically clinical investigator Dr. James Thompson, revealed significant deviations from the investigational plan and study protocol. The inspection identified issues including the enrollment of ineligible subjects, failure to assess and record adverse events, missing required subject records, and the use of unblinded personnel for follow-up calls. These findings indicate a lack of adherence to proper clinical study conduct.