# FDA 483 - University of Miami School of Medicine - September 14, 2026

Source: https://www.keypedia.com/records/483/university-of-miami-school-of-medicine/2440ee29-eb46-459c-b593-c357db47c27f

> FDA 483 for University of Miami School of Medicine on September 14, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of Miami School of Medicine
- Inspection Date: 2026-09-14
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of the University of Miami School of Medicine revealed significant deficiencies in clinical trial conduct. Observations included multiple protocol deviations, untimely provision of consent forms, and numerous IRB-related issues such as delayed reporting of adverse events and failure to update consent forms. Additionally, issues with study drug accountability, lack of documentation for consent obtainment, and unreported adverse events from lab results were cited.

## Related Officers

- [Victor Spanioli](https://www.keypedia.com/people/victor-spanioli/16437a61-6285-4bd8-b4f5-68186d475555)

Company: https://www.keypedia.com/companies/university-of-miami-school-of-medicine/6194d5ec-8eb1-4428-8a6e-2ee59310bbed

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6