FDA Inspection 1120420 — Georgetown University IRB
The FDA completed an inspection of Georgetown University IRB on March 11, 2020 in Washington, DC. 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
- March 11, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Washington, DC (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |