FDA Inspection
Children's Hospital Colorado, Blood bankChildren's Hospital Colorado, Blood bank – FDA Inspection, Feb 10, 2010
Record Details
This FDA Inspection record concerns Children's Hospital Colorado, Blood bank, with an inspection on February 10, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 10, 2010
- Product Type
- Biologics
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ID · b40588e7-460a-4ce2-9ac3-8cbf72b3b697
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 644669
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
16- 21 CFR 640.4(h)Storage temperatures after collection
- 21 CFR 606.160(e)(1)Donor deferral record - each location
- 21 CFR 606.100(a)SOP compliance
- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(b)Written SOPs available for use by personnel
- 21 CFR 640.61Written consent
- 21 CFR 640.25(a)Storage temps./agitation
- 21 CFR 640.25(b)Quality control
- 21 CFR 606.160(a)(1)Concurrent documentation
Showing 10 of 16 citations.
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Other FDA inspections of Children's Hospital Colorado, Blood bank
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2025 | Not classified | Denver District Office | |
| June 21, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 10, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 11, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 17, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Children's Hospital Colorado, Blood bank
- FDA Inspection 1274639 - 2025-06-06
- FDA Inspection 1095304 - 2019-06-21
- FDA Inspection 1094002 - 2019-05-10
- FDA Inspection 991589 - 2016-10-11
- FDA Inspection 833281 - 2013-05-17
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