FDA 483 - Veronique Sebastian, M.D. - May 25, 2023

An FDA inspection of Veronique Sebastian, M.D. in Oklahoma City, OK, revealed significant deficiencies in the conduct of clinical investigations. Observations included inadequate investigational drug disposition records and failure to conduct studies in accordance with the investigational plan. These findings indicate a need for improved oversight and adherence to study protocols, specifically regarding subject drug returns, dosing compliance, and timely performance of required examinations and laboratory assessments.