FDA Inspection
North Colorado Medical Center Blood BankNorth Colorado Medical Center Blood Bank – FDA Inspection, Feb 24, 2010
Record Details
This FDA Inspection record concerns North Colorado Medical Center Blood Bank, with an inspection on February 24, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 24, 2010
- Product Type
- Biologics
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ID · 3ee57885-d8cb-4d3a-ae69-712162c70b8e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 650590
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
8- 21 CFR 606.165(a)Distribution and receipt - recalls
- 21 CFR 606.140(b)Provisions to monitor lab test procedures & instruments
- 21 CFR 606.160(b)Required records
- 21 CFR 640.25(b)Quality control
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of North Colorado Medical Center Blood Bank
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 17, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 3, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 20, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 1, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for North Colorado Medical Center Blood Bank
- FDA Inspection 1172087 - 2022-06-07
- FDA Inspection 1057280 - 2018-05-17
- FDA Inspection 982328 - 2016-06-03
- FDA Inspection 883409 - 2014-06-20
- FDA Inspection 771157 - 2012-03-01
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