FDA Inspection 683787 — Institutional Review Board Of Swedish Health Services
The FDA completed an inspection of Institutional Review Board Of Swedish Health Services on Oct 1, 2010 in Seattle, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 1, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Seattle, WA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7323 | 21 CFR 56.111(a)(3) | Selection of subjects equitable |
| 7324 | 21 CFR 56.111(a)(4) | Informed consent sought |
| 7370 | 21 CFR 56.111(c) | Children as subjects |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |