FDA Inspection
St. Joseph's Health Hospital IRBSt. Joseph's Health Hospital IRB – FDA Inspection, Jan 24, 2017
Record Details
This FDA Inspection record concerns St. Joseph's Health Hospital IRB, with an inspection on January 24, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · cef212b2-a3e6-454e-90e4-cef680d3d188
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 999976
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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Other FDA inspections of St. Joseph's Health Hospital IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 3, 2023 | NAI | Bioresearch Monitoring | |
| May 20, 2009 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for St. Joseph's Health Hospital IRB
- FDA Inspection 1222298 - 2023-10-03
- FDA Inspection 583314 - 2009-05-20
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