FDA Inspection 829511 — The Baylor Scott & White Research Institute IRB, Temple
The FDA completed an inspection of The Baylor Scott & White Research Institute IRB, Temple on May 3, 2013 in Temple, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 3, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Temple, TX (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7274 | 21 CFR 56.107(a) | At least five members with varying backgrounds |
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7352 | 21 CFR 50.51 | Provisions for soliciting assent and permission |
| 7353 | 21 CFR 50.52 | Factors required for approval |