FDA Inspection 1263867 — Els Van Nieuwenhuysen, MD
The FDA completed an inspection of Els Van Nieuwenhuysen, MD on March 14, 2025 in Leuven. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 14, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Leuven (Belgium)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 22727 | 21 CFR 312.64(b) | Safety Reports - Serious Events |