FDA Inspection
St Joseph Mercy Oakland Instiutional Review BoardSt Joseph Mercy Oakland Instiutional Review Board – FDA Inspection, Apr 22, 2013
Record Details
This FDA Inspection record concerns St Joseph Mercy Oakland Instiutional Review Board, with an inspection on April 22, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 22, 2013
- Product Type
- Devices
View Company Profile
ID · 1a3a57e2-a396-471a-bb1e-28a1c3eb4744
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 829974
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.111(a)(1)Risks minimized by using procedures already being performed
- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.109(e)IRB approvals/disapprovals - general
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
- 21 CFR 56.113Reporting
Full citation text and observation details available on the Dashboard.
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 |
| September 14, 2018 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 21, 2015 | 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 1066898 - 2018-09-14
- FDA Inspection 924001 - 2015-04-21
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.