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

During an inspection conducted from March 10 to March 14, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Dr. Els (NMI) Van Nieuwenhuysen, a clinical investigator located in Leuven, Belgium. The inspection identified one significant observation: a failure to promptly report serious adverse events (SAEs) to the study sponsor. Specifically, the FDA noted an instance where a study subject developed a small bowel sub obstruction on June 14, 2022, which the investigator became aware of on the same day. However, this serious adverse event was not reported to the sponsor until June 24, 2022, a delay of ten days. This observation highlights a critical non-compliance with regulatory expectations for the timely notification of significant patient safety information during clinical trials. The FDA 483 document, issued under the authority of the Federal Food, Drug, and Cosmetic Act, serves as a record of objectionable conditions or practices observed during an inspection. It is not a final determination of compliance, but rather prompts the inspected entity to address the identified issues. Dr. Van Nieuwenhuysen is expected to respond to this observation, outlining corrective actions implemented or planned to ensure prompt reporting of all future serious adverse events to the sponsor.