University of Miami School of Medicine – FDA 483, Sep 14, 1998

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.