FDA Inspection
St Joseph Mercy Oakland Instiutional Review BoardSt Joseph Mercy Oakland Instiutional Review Board – FDA Inspection, Sep 14, 2018
Record Details
This FDA Inspection record concerns St Joseph Mercy Oakland Instiutional Review Board, with an inspection on September 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 14, 2018
- Product Type
- Devices
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ID · bd5114bb-818d-4f5a-b06d-1916988bc101
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066898
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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Other FDA inspections of St Joseph Mercy Oakland Instiutional Review Board
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2025 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 21, 2015 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 22, 2013 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for St Joseph Mercy Oakland Instiutional Review Board
- FDA Inspection 1276122 - 2025-07-16
- FDA Inspection 924001 - 2015-04-21
- FDA Inspection 829974 - 2013-04-22
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