FDA Inspection
Thomas Jefferson University Institutional Review BoardThomas Jefferson University Institutional Review Board – FDA Inspection, Jun 18, 2015
Record Details
This FDA Inspection record concerns Thomas Jefferson University Institutional Review Board, with an inspection on June 18, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 18, 2015
- Product Type
- Devices
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ID · 2e3a3c12-bd4c-40bf-a74d-96d88c8c02a9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 932060
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(a)(3)Records of continuing review
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.110(b)Research not eligible for expedited review
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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 | |
| February 15, 2019 | OAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
| June 28, 2018 | NAI | Center for Drug Evaluation and Research | 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 1079433 - 2019-02-15
- FDA Inspection 1058719 - 2018-06-28
- FDA Inspection 872228 - 2014-03-27
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