FDA Inspection
Asante Health System IRB dba Southern Oregon IRBAsante Health System IRB dba Southern Oregon IRB – FDA Inspection, May 5, 2017
Record Details
This FDA Inspection record concerns Asante Health System IRB dba Southern Oregon IRB, with an inspection on May 5, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f9c4bf8c-7240-4df4-acb8-c843f28c0380
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1010448
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
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Other FDA inspections of Asante Health System IRB dba Southern Oregon IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 10, 2025 | Not classified | Seattle District Office | |
| November 22, 2011 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Asante Health System IRB dba Southern Oregon IRB
- FDA Inspection 1258239 - 2025-01-10
- FDA Inspection 755369 - 2011-11-22
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