FDA Inspection
Children's Hospital Colorado, Blood bankChildren's Hospital Colorado, Blood bank – FDA Inspection, May 17, 2013
Record Details
This FDA Inspection record concerns Children's Hospital Colorado, Blood bank, with an inspection on May 17, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 17, 2013
- Product Type
- Biologics
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ID · b3a75d77-6eaf-4ab5-970f-a6289c8d5861
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 833281
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 15, 2012 | OAI | 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 780127 - 2012-05-15
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