FDA 483 - David M. Scarpino, M.D. - January 16, 2026

The FDA inspected David M. Scarpino, M.D., a clinical investigator, and identified significant deviations from the investigational plan and good clinical practices. Observations included failures to ensure subject eligibility, maintain accurate and complete case histories, and properly manage investigational drug disposition. These findings raise concerns about data integrity and adherence to study protocols.