FDA 483 - Frederic Caux - June 06, 2025

An FDA inspection conducted from June 3-6, 2025, at the facility of Frederic Caux, a Clinical Investigator located in Bobigny, France, resulted in a Form FDA 483 observation. The primary issue identified was a failure to prepare or maintain accurate case histories with respect to observations and data pertinent to the investigation.

Specifically, the inspection revealed that for a subject identified as (b)(6), who required rescue treatment with topical corticosteroids at Visit 11/Week 18 for a relapse of Bullous Pemphigoid, the investigator did not report this crucial treatment to the study sponsor within the data capture system. The protocol clearly outlined that patients experiencing a relapse after tapering off Oral Corticosteroids (OCS) could be rescued, including with high-potency topical corticosteroids, OCS re-initiation, or systemic non-steroidal immunosuppressive drugs/immunomodulating biologics. The omission of this significant rescue treatment from the records constitutes a violation of regulatory expectations for clinical trials.

This observation, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, indicates a deviation from good clinical practice. Frederic Caux is required to review this observation, investigate its root cause, and implement timely and effective corrective and preventive actions to ensure the accuracy and completeness of all study documentation and data reporting in future clinical investigations. Prompt discussion with FDA representatives or submission of a formal response detailing these actions is expected.