FDA 483 - Robert S. Call, M.D. - October 19, 2022

An FDA inspection of Robert S. Call, M.D., a clinical investigator in Richmond, VA, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to follow investigational plans, ensure contemporaneous assessment of lab results, and timely report adverse events. Additionally, the firm failed to maintain adequate and accurate case histories, with missing informed consent forms, source records, and numerous discrepancies between source and electronic data.