FDA Inspection 986266 — Howard University Institutional Review Board
The FDA completed an inspection of Howard University Institutional Review Board on August 4, 2016 in Washington, DC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 4, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Washington, DC (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7279 | 21 CFR 56.107(f) | Invited individual allowed to vote with IRB |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7319 | 21 CFR 56.115(a)(3) | Records of continuing review |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7324 | 21 CFR 56.111(a)(4) | Informed consent sought |
| 7334 | 21 CFR 56.115(a)(5) | List of members |