FDA Inspection
North Memorial Medical Center IRBNorth Memorial Medical Center IRB – FDA Inspection, Mar 30, 2010
Record Details
This FDA Inspection record concerns North Memorial Medical Center IRB, with an inspection on March 30, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 30, 2010
- Product Type
- Devices
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ID · f2ac7a7a-5cf7-4538-aa7d-7ecb52afa9eb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 657218
- 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 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.110(b)Research not eligible for expedited review
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Other FDA inspections of North Memorial Medical Center IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 6, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 10, 2011 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for North Memorial Medical Center IRB
- FDA Inspection 985522 - 2016-09-06
- FDA Inspection 738398 - 2011-08-10
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