FDA Inspection
McLaren Health Care Corporate Institutional Review BoardMcLaren Health Care Corporate Institutional Review Board – FDA Inspection, Apr 8, 2010
Record Details
This FDA Inspection record concerns McLaren Health Care Corporate Institutional Review Board, with an inspection on April 8, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 8, 2010
- Product Type
- Devices
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ID · b5b7b861-9c00-4d3f-bde5-72be9d9f2a0d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 661012
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.109(f)Continuing review
- 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records
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Other FDA inspections of McLaren Health Care Corporate Institutional Review Board
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 21, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 3, 2012 | VAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
Other documents for McLaren Health Care Corporate Institutional Review Board
- FDA Inspection 1012572 - 2017-04-21
- FDA Inspection 789660 - 2012-07-03
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