FDA Inspection 1305456 — Seattle Children's Hospital IRB
The FDA completed an inspection of Seattle Children's Hospital IRB on March 3, 2026 in Seattle, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 3, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Seattle, WA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7276 | 21 CFR 56.107(c) | One scientific and one non-scientific member |
| 7277 | 21 CFR 56.107(d) | One non-affiliate member |