FDA 483 - Enrico Bertini MD - May 05, 2025

An FDA inspection of Clinical Investigator Enrico Bertini in Rome, Italy, revealed a significant issue regarding the maintenance of adequate case histories. The inspection found that source records and case report forms for a study, including data related to mFARS, walking tests, pharmacy activities, and investigator oversight, were not accurate, attributable, legible, complete, or contemporaneous. This indicates a serious concern with data integrity and record-keeping practices in the clinical investigation.