FDA Inspection
Advocate Health Care IRBAdvocate Health Care IRB – FDA Inspection, May 14, 2010
Record Details
This FDA Inspection record concerns Advocate Health Care IRB, with an inspection on May 14, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Advocate Health Care IRB
- Inspection Date
- May 14, 2010
- Product Type
- Biologics
View Company Profile
ID · 6bc932fe-c459-4835-a13c-64752cc3fac1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 661898
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(a)(1)Initial and continuing reviews
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Advocate Health Care IRB
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2021 | NAI | Bioresearch Monitoring | |
| September 11, 2015 | VAI | Center for Food Safety and Applied Nutrition | Bioresearch Monitoring |
| November 8, 2013 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 30, 2011 | OAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Advocate Health Care IRB
- FDA Inspection 1168330 - 2021-11-19
- FDA Inspection 941503 - 2015-09-11
- FDA Inspection 853669 - 2013-11-08
- FDA Inspection 756400 - 2011-11-30
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