FDA Inspection 1196717 — Children's Healthcare IRB #1
The FDA completed an inspection of Children's Healthcare IRB #1 on February 3, 2023 in Minneapolis, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 3, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Minneapolis, MN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7290 | 21 CFR 56.108(c) | Members present for review |