FDA 483 - Danny Rischin, MBBS, FRACP, MD - September 18, 2025

An FDA inspection of Danny Rischin, MBBS, FRACP, MD, a clinical investigator in Melbourne, Australia, revealed significant issues with clinical trial data integrity and protocol adherence. The firm failed to accurately report case histories, including adverse events and concomitant medications, and did not conduct investigations in accordance with the study protocol, specifically regarding required radiologic imaging timepoints.