FDA Inspection
The University of Texas at Austin IRBThe University of Texas at Austin IRB – FDA Inspection, Feb 25, 2015
Record Details
This FDA Inspection record concerns The University of Texas at Austin IRB, with an inspection on February 25, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 25, 2015
- Product Type
- Devices
View Company Profile
ID · dd8bb8bb-cfd2-4ee5-955e-ba2e0fe9059d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 911623
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(3)Records of continuing review
- 21 CFR 50.25(c)ClincialTrials.gov statement
- 21 CFR 56.110(b)Research not eligible for expedited review
- 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of The University of Texas at Austin IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 3, 2021 | NAI | Bioresearch Monitoring |
Other documents for The University of Texas at Austin IRB
- FDA Inspection 1156504 - 2021-11-03
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.