FDA Inspection 645966 — Seattle Children's Hospital IRB
The FDA completed an inspection of Seattle Children's Hospital IRB on January 27, 2010 in Seattle, WA. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 27, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Seattle, WA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |