FDA 483 - Rima Nabbout, M.D.

Rima Nabbout, M.D., Clinical Investigator, located in Paris, France, was inspected by the FDA from February 3-7, 2020, regarding bioresearch monitoring. The inspection revealed a significant issue with the failure to maintain adequate and accurate case histories. Specifically, records for study subjects lacked indications of data source, recorder, date, and confirmation of submission to the study sponsor.