FDA Inspection
Georgetown University IRBGeorgetown University IRB – FDA Inspection, Mar 11, 2020
Record Details
This FDA Inspection record concerns Georgetown University IRB, with an inspection on March 11, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Georgetown University IRB
- Inspection Date
- March 11, 2020
- Product Type
- Devices
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ID · d66b3c2c-59b7-4e02-9742-da1e8355c692
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1120420
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 56.115(a)(2)Minutes of IRB meetings
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Georgetown University IRB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2025 | Not classified | Baltimore District Office | |
| August 3, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| February 5, 2009 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Georgetown University IRB
- FDA Inspection 1293802 - 2025-11-21
- FDA Inspection 938814 - 2015-08-03
- FDA Inspection 573787 - 2009-02-05
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