FDA Inspection
Montana State University- Bozeman IRBMontana State University- Bozeman IRB – FDA Inspection, Aug 2, 2018
Record Details
This FDA Inspection record concerns Montana State University- Bozeman IRB, with an inspection on August 2, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9fbab9a2-eb97-4cc9-8597-f6f23c067d1a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060799
- 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)(2)Minutes of IRB meetings
- 21 CFR 56.115(a)(3)Records of continuing review
- 21 CFR 56.111(a)(1)Risks minimized by using procedures already being performed
- 21 CFR 56.111(a)(6)Monitoring of data collected
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