FDA 483 - Rima Nabbout, M.D. - February 07, 2020

During an inspection conducted from February 3-7, 2020, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Dr. Rima Nabbout, a Clinical Investigator at Hopital Necker Enfants Malades, H'Pital Universitaire Necker-Enfants Malades in Paris, France. The inspection focused on Study Protocol ZX008-1504, a trial investigating ZX008 (fenfluramine hydrochloride) for Dravet Syndrome. The primary observation noted was the failure to prepare or maintain adequate and accurate case histories. Specifically, Manual Seizure Diary Entry Request Template records and End of Day Review Diary Data Capture Forms for study subjects lacked crucial information. These documents did not indicate the source of the recorded data, the individual responsible for recording it, or the date of recording. Furthermore, these critical study documents did not include confirmation of their submission to the study sponsor. These observations were made pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act. While the 483 form itself does not mandate specific actions, it serves as notification of objectionable conditions, indicating that Dr. Nabbout and the institution are expected to review these findings and implement appropriate corrective actions to ensure proper data management and record-keeping in clinical investigations, thereby ensuring the integrity and reliability of study data.