FDA Inspection 573578 — Staten Island University Hospital IRB
The FDA completed an inspection of Staten Island University Hospital IRB on Apr 3, 2009 in Staten Island, NY. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 3, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Staten Island, NY (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7387 | 21 CFR 50.25(a)(1) | Statement of research, purpose, duration of participation |
| 7389 | 21 CFR 50.25(a)(3) | Benefits to the subject |
| 7659 | 21 CFR 50.25(a)(6) | Compensation, medical treatment in event of injury |
| 7665 | 21 CFR 50.20 | Exculpatory language, waiving of rights |