FDA EIR - Flavio Vincenti, M.D. - November 04, 2009

An FDA inspection of Flavio Vincenti, M.D., conducted from October 21 to November 4, 2009, identified significant deficiencies in the conduct of clinical investigations under the Bioresearch Monitoring Compliance Program, specifically citing violations of 21 CFR 312.60. The primary finding was that studies were not conducted in accordance with the investigational plan and the signed statement of investigator. Key issues included the enrollment of three subjects in a clinical trial (Protocol (redacted)) who did not meet crucial eligibility criteria, as they had a (redacted) condition specifically excluded by the protocol for a (redacted) therapy. Furthermore, for one of these ineligible subjects, a serious adverse event (cardiac arrest resulting in death) was not immediately reported to the study sponsor, showing a significant delay from the event date to the sponsor notification. Another critical observation was that two active subjects in a separate study (Protocol (redacted)) had not consented to the most current, IRB-approved version of the informed consent form, continuing participation based on an outdated version. The firm also failed to report critical protocol deviations, particularly those related to eligibility criteria, to the Institutional Review Board within the mandated timeframe. Consequently, an FDA Form 483, detailing these inspectional observations, was issued to Dr. Vincenti. He acknowledged the findings and committed to submitting a written response within fifteen working days, outlining corrective actions to address the identified issues and ensure compliance with federal regulations.