FDA Inspection 938814 — Georgetown University IRB
The FDA completed an inspection of Georgetown University IRB on Aug 3, 2015 in Washington, DC. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 3, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Washington, DC (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7353 | 21 CFR 50.52 | Factors required for approval |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |