FDA Inspection
Thomas Jefferson University Institutional Review BoardThomas Jefferson University Institutional Review Board – FDA Inspection, Feb 15, 2019
Record Details
This FDA Inspection record concerns Thomas Jefferson University Institutional Review Board, with an inspection on February 15, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 15, 2019
- Product Type
- Biologics
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ID · e370ecad-373a-4536-8522-44539473c15b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1079433
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.110(c)Method to keep members advised
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Other FDA inspections of Thomas Jefferson University Institutional Review Board
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 7, 2022 | NAI | Bioresearch Monitoring | |
| June 28, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 18, 2015 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 27, 2014 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Thomas Jefferson University Institutional Review Board
- FDA Inspection 1195142 - 2022-12-07
- FDA Inspection 1058719 - 2018-06-28
- FDA Inspection 932060 - 2015-06-18
- FDA Inspection 872228 - 2014-03-27
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