FDA 483 - Mario Campone - November 07, 2025

An FDA inspection of Mario Campone, MD, PHD, a clinical investigator in Saint Herblain Cedex, France, revealed significant issues with the accuracy of case histories for a Phase 3 clinical trial. Specifically, the firm failed to report all non-serious adverse events and concomitant medications for subjects randomized into the study. This indicates deficiencies in data integrity and reporting practices during the clinical investigation.