FDA Inspection 1004687 — Gerrit J. Bouma, MD
The FDA completed an inspection of Gerrit J. Bouma, MD on Mar 10, 2017 in Amsterdam. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 10, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Amsterdam (Netherlands)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |