FDA Inspection 1107475 — Herman H. Schroe, MD
The FDA completed an inspection of Herman H. Schroe, MD on October 25, 2019 in Genk. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 25, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Genk (Belgium)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |