FDA Inspection 626561 — Providence Hospital Institutional Review Board
The FDA completed an inspection of Providence Hospital Institutional Review Board on November 3, 2009 in Washington, DC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 3, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Washington, DC (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7277 | 21 CFR 56.107(d) | One non-affiliate member |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |