FDA Inspection
Saint Alphonsus Institutional Review BoardSaint Alphonsus Institutional Review Board – FDA Inspection, Sep 18, 2024
Record Details
This FDA Inspection record concerns Saint Alphonsus Institutional Review Board, with an inspection on September 18, 2024, issued by the Seattle District Office, covering medical devices & rad health.
- Inspection Date
- September 18, 2024
- Product Type
- Medical Devices & Rad Health
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ID · fd1ec20d-0c1b-4006-9d74-ad1f33561c2c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1249592
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring: Human Drugs
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 56.106(e)Changes in contact or chairperson information
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.106(b)(3)Number of active protocols
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Other FDA inspections of Saint Alphonsus Institutional Review Board
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 29, 2014 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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