FDA Inspection
Sky Lakes Medical Center Institutional Review BoardSky Lakes Medical Center Institutional Review Board – FDA Inspection, Aug 4, 2011
Record Details
This FDA Inspection record concerns Sky Lakes Medical Center Institutional Review Board, with an inspection on August 4, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 4, 2011
- Product Type
- Drugs
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ID · 7c1533a9-6a21-4030-9920-3733b892e673
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 739699
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 21 CFR 56.109(b)Information given to subjects
- 21 CFR 56.110(b)(1)No more than minimal risk
- 21 CFR 56.110(b)Research not eligible for expedited review
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