FDA Inspection 1079433 — Thomas Jefferson University Institutional Review Board
The FDA completed an inspection of Thomas Jefferson University Institutional Review Board on Feb 15, 2019 in Philadelphia, PA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 15, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Philadelphia, PA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 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 |