FDA 483 - Deirdre O. Hooper, M.D. - September 10, 2025

An FDA inspection of Deirdre O. Hooper, M.D., a clinical investigator in New Orleans, LA, revealed issues with data accuracy. Specifically, subject case history records were found to be inaccurate, with discrepancies between electronic data capture (EDC) system entries and original source records for multiple subjects and visits. This indicates a significant concern regarding data integrity in clinical trial documentation.