FDA Inspection 932060 — Thomas Jefferson University Institutional Review Board
The FDA completed an inspection of Thomas Jefferson University Institutional Review Board on June 18, 2015 in Philadelphia, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 18, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Philadelphia, PA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7319 | 21 CFR 56.115(a)(3) | Records of continuing review |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |