FDA Inspection 553032 — BRI Institutional Review Board, Inc.
The FDA completed an inspection of BRI Institutional Review Board, Inc. on December 10, 2008 in Houston, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 10, 2008
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Houston, TX (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7270 | 21 CFR 56.103(a) | IRB review requirement |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |