FDA Inspection
Indiana University IRBIndiana University IRB – FDA Inspection, Dec 12, 2013
Record Details
This FDA Inspection record concerns Indiana University IRB, with an inspection on December 12, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Indiana University IRB
- Inspection Date
- December 12, 2013
- Product Type
- Drugs
View Company Profile
ID · 740a6572-031e-4a14-8ac5-57da3f9b1c98
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 858661
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 56.108(c)Members present for review
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Indiana University IRB
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2025 | Not classified | Detroit District Office | |
| February 14, 2020 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 3, 2016 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 29, 2011 | OAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 2, 2010 | NAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
Other documents for Indiana University IRB
- FDA Inspection 1279195 - 2025-08-08
- FDA Inspection 1117830 - 2020-02-14
- FDA Inspection 971053 - 2016-05-03
- FDA Inspection 748356 - 2011-09-29
- FDA Inspection 664415 - 2010-06-02
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