FDA 483 - Vincent A. Restivo - May 26, 2023

Vincent A. Restivo, MD, a clinical investigator in Cedar Park, TX, was issued a Form 483 following an inspection from May 22-26, 2023. The inspection revealed significant issues in the conduct of a clinical investigation, including failures to report adverse events, adhere to the investigational plan regarding dosing diaries, and maintain accurate case histories. These deficiencies indicate a lack of proper oversight and data integrity in the clinical trial.