FDA Inspection 1111766 — Jackson-Madison County General Hospital IRB
The FDA completed an inspection of Jackson-Madison County General Hospital IRB on November 26, 2019 in Jackson, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 26, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Jackson, TN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7274 | 21 CFR 56.107(a) | At least five members with varying backgrounds |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7370 | 21 CFR 56.111(c) | Children as subjects |