FDA Inspection 782855 — Texas Applied Biotechnology Research Review Committee
The FDA completed an inspection of Texas Applied Biotechnology Research Review Committee on April 25, 2012 in Houston, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 25, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Houston, TX (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 7309 | 21 CFR 56.111(a)(1) | Risks minimized by sound research design |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7358 | 21 CFR 50.55(a) | Adequate provisions for assent of children |
| 7383 | 21 CFR 50.25(b)(6) | Number of subjects in study |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |
| 7389 | 21 CFR 50.25(a)(3) | Benefits to the subject |
| 7390 | 21 CFR 50.25(a)(4) | Alternate procedures, courses of treatment |