FDA Inspection
M Health Fairview University of Minnesota Medical Center, West Bank -Blood BankM Health Fairview University of Minnesota Medical Center, West Bank -Blood Bank – FDA Inspection, Feb 10, 2012
Record Details
This FDA Inspection record concerns M Health Fairview University of Minnesota Medical Center, West Bank -Blood Bank, with an inspection on February 10, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 10, 2012
- Product Type
- Biologics
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ID · 755cddd1-6c6c-4419-9fc0-bcb0b464ddde
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 767505
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 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, West Bank -Blood Bank
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| October 31, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 8, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 14, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for M Health Fairview University of Minnesota Medical Center, West Bank -Blood Bank
- FDA Inspection 1166873 - 2022-03-18
- FDA Inspection 1032409 - 2017-10-31
- FDA Inspection 951660 - 2015-12-08
- FDA Inspection 866331 - 2014-02-14
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