FDA 483 - Els Van Nieuwenhuysen, MD - March 14, 2025

Els Van Nieuwenhuysen, MD, a clinical investigator in Leuven, Belgium, was inspected by the FDA from March 10-14, 2025. The inspection identified a failure to promptly report serious adverse events to the study sponsor. Specifically, one subject's small bowel sub obstruction was reported 10 days after the investigator became aware of the event.