FDA Inspection
M Health Fairview University of Minnesota Medical Center, East Bank-Blood BankM Health Fairview University of Minnesota Medical Center, East Bank-Blood Bank – FDA Inspection, Jul 30, 2013
Record Details
This FDA Inspection record concerns M Health Fairview University of Minnesota Medical Center, East Bank-Blood Bank, with an inspection on July 30, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 30, 2013
- Product Type
- Biologics
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ID · 5d976fed-b848-4b5b-95e1-bab597dd1d48
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 842523
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.170(a)Adverse Reaction - Investigations
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of M Health Fairview University of Minnesota Medical Center, East Bank-Blood Bank
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 6, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 18, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 8, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 22, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 25, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for M Health Fairview University of Minnesota Medical Center, East Bank-Blood Bank
- FDA Inspection 1251216 - 2024-09-06
- FDA Inspection 1071058 - 2018-10-18
- FDA Inspection 1001549 - 2017-02-08
- FDA Inspection 909076 - 2014-12-22
- FDA Inspection 743550 - 2011-08-25
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