FDA Inspection 1071627 — Prof Dirk Van Raemdonck
The FDA completed an inspection of Prof Dirk Van Raemdonck on Nov 9, 2018 in Leuven. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 9, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Leuven (Belgium)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |