FDA Inspection
Indiana University IRBIndiana University IRB – FDA Inspection, Sep 29, 2011
Record Details
This FDA Inspection record concerns Indiana University IRB, with an inspection on September 29, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Indiana University IRB
- Inspection Date
- September 29, 2011
- Product Type
- Drugs
View Company Profile
ID · 7d6fdf1d-ca76-4e73-8f4e-babb66573244
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 748356
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
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 |
| December 12, 2013 | VAI | 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 858661 - 2013-12-12
- FDA Inspection 664415 - 2010-06-02
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