FDA 483 - Robert S. Call, M.D. - March 25, 2021

An FDA inspection of Robert S. Call, M.D., a clinical investigator in Richmond, VA, revealed two significant observations. The firm failed to conduct an investigation according to the approved plan, specifically by missing required safety and laboratory assessments for a subject. Additionally, the firm did not maintain adequate and accurate case histories, as evidenced by unreported adverse events and concomitant medications.