FDA 483 - Ramy A. Fayad, M.D. - December 18, 2024

An FDA inspection of Ramy A. Fayad, M.D. in Toledo, OH, identified a significant issue regarding the timely reporting of serious adverse events. The clinical investigator failed to adhere to protocol requirements for reporting an SAE, specifically a subject's hospitalization for pneumonia, within the specified timeframe. This indicates a lapse in adherence to clinical trial protocols for patient safety reporting.