FDA Inspection
Seton Family of Hospitals Institutional Review Board (SFOH IRB)Seton Family of Hospitals Institutional Review Board (SFOH IRB) – FDA Inspection, Jan 9, 2015
Record Details
This FDA Inspection record concerns Seton Family of Hospitals Institutional Review Board (SFOH IRB), with an inspection on January 9, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 9, 2015
- Product Type
- Drugs
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ID · 3933f8ee-16ba-4afb-93cc-05739a16c45a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 909617
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(5)List of members
- 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 Seton Family of Hospitals Institutional Review Board (SFOH IRB)
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 16, 2009 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Seton Family of Hospitals Institutional Review Board (SFOH IRB)
- FDA Inspection 1083450 - 2019-03-22
- FDA Inspection 557184 - 2009-01-16
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