FDA 483 - Howard M. Richard, III M.D. - March 06, 2023

The FDA inspected the University of Maryland Medical Center, Department of Diagnostic Radiology and Nuclear Medicine, a clinical investigator site. The inspection revealed significant deviations from the investigational plan for a device study, including enrolling ineligible subjects and failing to timely report serious adverse events and screen failures. Additionally, the facility's records for the receipt, use, and disposal of the investigational device were found to be inaccurate and incomplete.