FDA 483 - Don A. Stevens, M.D. - April 13, 2023

An FDA inspection of Don A. Stevens, M.D., a clinical investigator in Louisville, KY, revealed significant deviations from good clinical practice. The firm failed to conduct an investigation in accordance with the investigational plan, including enrolling an ineligible subject and delaying adverse event reporting. Additionally, the inspection found a failure to maintain accurate case histories, with discrepancies between source documents and electronic case report forms.