FDA Inspection
North Colorado Medical Center Blood BankNorth Colorado Medical Center Blood Bank – FDA Inspection, Jun 20, 2014
Record Details
This FDA Inspection record concerns North Colorado Medical Center Blood Bank, with an inspection on June 20, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 20, 2014
- Product Type
- Biologics
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ID · 3d2a184c-b274-4620-901d-61570334527c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 883409
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 211.192Quality control unit review of records
- 21 CFR 606.165(a)Distribution and receipt - recalls
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.160(a)(1)Concurrent documentation
- 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 |
| March 1, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 24, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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 771157 - 2012-03-01
- FDA Inspection 650590 - 2010-02-24
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