FDA 483 - Enrico Bertini MD - May 09, 2025

An FDA 483 inspection conducted from May 5-9, 2025, at the facility of Clinical Investigator Enrico Bertini in Roma, Italy, identified significant deficiencies in the maintenance of essential study documentation. The inspection revealed a failure to uphold adequate case histories, a critical aspect of regulatory compliance for clinical investigations. Specifically, the observations highlighted that source records and case report forms related to key study components, including modified Friedreich Ataxia Rating Scale (mFARS) assessments, 1-minute walking tests, pharmacy activities, and investigator oversight, lacked the necessary attributes of accuracy, attributability, legibility, completeness, and contemporaneity. These findings indicate a lapse in ensuring the integrity and reliability of clinical trial data. Issued by Investigator Gabrielle J. Swain, this FDA Form 483 serves as an official notification of inspectional observations, not a final determination of compliance. To address these issues, Dr. Bertini is expected to evaluate the observations, discuss any objections, and implement robust corrective and preventive actions to rectify the noted record-keeping deficiencies and ensure future adherence to regulatory standards governing clinical research.