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

Source: https://www.keypedia.com/records/483/danny-rischin-mbbs-fracp-md/3d3dc856-a3e8-4e18-9499-fb99d1a2d1ee

> FDA 483 for Danny Rischin, MBBS, FRACP, MD on September 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Danny Rischin, MBBS, FRACP, MD
- Inspection Date: 2025-09-18
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/tawny-l-colling/4ce51467-468c-4271-a98d-4b13c15c0812)

Company: https://www.keypedia.com/companies/danny-rischin-mbbs-fracp-md/6fe55dea-b7e1-4cfa-8932-3e78386fe184

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd