FDA Inspection 1016144 — East Tennessee Children's Hospital IRB
The FDA completed an inspection of East Tennessee Children's Hospital IRB on June 26, 2017 in Knoxville, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 26, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Knoxville, TN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7297 | 21 CFR 56.109(b) | Information given to subjects |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |