FDA Inspection
Rush University Medical Center IRBRush University Medical Center IRB – FDA Inspection, Apr 2, 2010
Record Details
This FDA Inspection record concerns Rush University Medical Center IRB, with an inspection on April 2, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 2, 2010
- Product Type
- Drugs
View Company Profile
ID · 874e5805-bc49-4a0a-8148-75eca82a0829
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 659896
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.109(h)Children as subjects
- 21 CFR 56.110(c)Method to keep members advised
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Rush University Medical Center IRB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2025 | Not classified | Chicago District Office | |
| May 18, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| November 13, 2013 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Rush University Medical Center IRB
- FDA Inspection 1281798 - 2025-09-12
- FDA Inspection 1054774 - 2018-05-18
- FDA Inspection 848512 - 2013-11-13
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.