FDA 483 - Frederic Caux - June 06, 2025

Frederic Caux, a clinical investigator in Bobigny, France, was cited for failing to prepare or maintain accurate case histories during an inspection. Specifically, the investigator did not report a subject's required rescue treatment with a high-potency topical corticosteroid cream for a Bullous Pemphigoid relapse to the study sponsor. This indicates a failure in data capture and adherence to protocol requirements.