FDA Inspection
HealthEast Institutional Review BoardHealthEast Institutional Review Board – FDA Inspection, Sep 13, 2018
Record Details
This FDA Inspection record concerns HealthEast Institutional Review Board, with an inspection on September 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · dc4f80e1-00fa-48f8-bd03-7883dcc3eeb2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065554
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 812.66No IRB notification of significant risk determination
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Other FDA inspections of HealthEast Institutional Review Board
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 3, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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