FDA Inspection
Swedish American Hosp IRBSwedish American Hosp IRB – FDA Inspection, Jun 6, 2018
Record Details
This FDA Inspection record concerns Swedish American Hosp IRB, with an inspection on June 6, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 66256167-be9d-477c-945c-b40b397b9693
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1054508
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.107(e)Conflict of interest
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Other FDA inspections of Swedish American Hosp IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 13, 2025 | NAI | Bioresearch Monitoring | |
| March 30, 2011 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Swedish American Hosp IRB
- FDA Inspection 1279445 - 2025-08-13
- FDA Inspection 715830 - 2011-03-30
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