FDA 483 - Nicolas J. Mouawad, MD - March 20, 2026

Nicolas J. Mouawad, MD, a clinical investigator in Bay City, MI, was cited for significant deficiencies in record-keeping during a device study inspection. Observations included inaccurate and incomplete device accountability records with conflicting lot numbers, insufficient documentation for the return or disposition of deficient devices, and a failure to properly identify subjects on source documentation related to device exposure. These issues indicate a lack of robust data integrity and accountability in the clinical investigation.