FDA Inspection 817018 — BRI Institutional Review Board, Inc.
The FDA completed an inspection of BRI Institutional Review Board, Inc. on February 7, 2013 in Houston, TX. 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: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 7, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Houston, TX (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7322 | 21 CFR 56.111 (a)(2) | Risks to subjects reasonable |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7369 | 21 CFR 56.109(h) | Children as subjects |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |