483
Mario CamponeFDA 483 - Mario Campone - November 07, 2025
Record Details
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.
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ID · 86e2864f-0daa-42e4-99cd-ecf2cf08e649