FDA Inspection
Eastern Idaho Regional Medical Center IRB, HCAEastern Idaho Regional Medical Center IRB, HCA – FDA Inspection, Aug 24, 2018
Record Details
This FDA Inspection record concerns Eastern Idaho Regional Medical Center IRB, HCA, with an inspection on August 24, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 24, 2018
- Product Type
- Drugs
- Person
- Lauren E. Swantko (Issuing Officer)
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ID · 63698f43-3b90-4261-a588-d91c3c262eeb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063537
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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Other FDA inspections of Eastern Idaho Regional Medical Center IRB, HCA
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 22, 2011 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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