FDA Inspection
Seton Family of Hospitals Institutional Review Board (SFOH IRB)Seton Family of Hospitals Institutional Review Board (SFOH IRB) – FDA Inspection, Mar 22, 2019
Record Details
This FDA Inspection record concerns Seton Family of Hospitals Institutional Review Board (SFOH IRB), with an inspection on March 22, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 22, 2019
- Product Type
- Biologics
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ID · 8038dd44-5d3f-42c4-b642-4c6260fb65e6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083450
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 56.115(b)Retention of records
- 21 CFR 56.109(h)Children as subjects
- 21 CFR 56.109(f)Continuing review
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Other FDA inspections of Seton Family of Hospitals Institutional Review Board (SFOH IRB)
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 9, 2015 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| 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 909617 - 2015-01-09
- FDA Inspection 557184 - 2009-01-16
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