FDA 483 - James A. Simon, MD - May 05, 2023

An FDA inspection of James A. Simon, MD, a clinical investigator in Washington, DC, revealed significant deficiencies in the conduct of a clinical investigation and control of investigational devices. The firm failed to ensure subjects met inclusion/exclusion criteria prior to randomization and did not properly account for investigational products. These findings indicate a lack of adherence to study protocols and regulatory requirements for clinical trials.