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

An FDA inspection conducted at Veronique Sebastian, M.D., also known as Sooner Clinical Research, from May 22-25, 2023, identified two significant observations documented in an FDA Form 483. The first observation concerned inadequate investigational drug disposition records. Specifically, for a particular study, three out of five subjects did not return their study drug bottles, making it impossible to determine actual drug use. There were also discrepancies between reported dosing compliance and documented drug dispensation. The second observation noted that the clinical investigation was not conducted in accordance with the approved investigational plan. Key issues included ophthalmologic examinations being performed outside the specified visit windows for multiple subjects, and in one instance, a baseline eye exam occurring after the initial study visit and a follow-up exam significantly past the required timeframe. Furthermore, several central laboratory assessments, such as urine drug screens and hematology tests, were not performed for various subjects at scheduled visits. These observations, issued under the Federal Food, Drug and Cosmetic Act, indicate a need for improved adherence to study protocols and record-keeping. Veronique Sebastian, M.D., is required to respond to these findings, outlining corrective actions implemented or planned.