FDA Inspection 1116412 — Children's Healthcare IRB #1
The FDA completed an inspection of Children's Healthcare IRB #1 on January 31, 2020 in Minneapolis, MN. 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
- January 31, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Minneapolis, MN (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 |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7381 | 21 CFR 50.27(b)(2) | Short form: Summary copy not signed/given |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |