FDA 483 - Robert M. Pascuzzi, M.D. - January 27, 2023

The FDA inspected Robert M. Pascuzzi, M.D. at the Indiana University Health Neuroscience Center, a clinical investigator site in Indianapolis. The inspection revealed that the investigation was not conducted in accordance with the signed statement of investigator and investigational plan. This included deviations in subject concomitant treatment criteria and improper handling of investigational product by a blinded study team.