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•Danny Rischin, MBBS, FRACP, MD•September 18, 2025

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

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Record Details

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.

Company
Danny Rischin, MBBS, FRACP, MD
Inspection Date
September 18, 2025
Product Type
Drugs
Office
Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person
  • Tawny L. Colling (investigator)
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ID · 3d3dc856-a3e8-4e18-9499-fb99d1a2d1ee

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