FDA Inspection
Sunrise Health Institutional Review BoardSunrise Health Institutional Review Board – FDA Inspection, May 3, 2018
Record Details
This FDA Inspection record concerns Sunrise Health Institutional Review Board, with an inspection on May 3, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e109625c-8463-4076-9b03-3f6ef827761d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1050583
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 56.112Approval by institution in absence of IRB approval
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Other FDA inspections of Sunrise Health Institutional Review Board
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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