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

Source: https://www.keypedia.com/records/483/els-van-nieuwenhuysen-md/ca57224d-699e-4652-9d9f-a6fffa3182e8

> FDA 483 for Els Van Nieuwenhuysen, MD on March 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Els Van Nieuwenhuysen, MD
- Inspection Date: 2025-03-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [Terri E. Gibson](https://www.keypedia.com/people/terri-e-gibson/f1a80f95-a5c4-4cae-9a4b-e23f367770bb)

Company: https://www.keypedia.com/companies/els-van-nieuwenhuysen-md/c4dedd97-84cc-44d7-aca9-c751dd683580

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8