FDA Inspection
Children's Hospital Colorado, Blood bankChildren's Hospital Colorado, Blood bank – FDA Inspection, Oct 11, 2016
Record Details
This FDA Inspection record concerns Children's Hospital Colorado, Blood bank, with an inspection on October 11, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · d296de6c-8fdc-420a-9c4c-ecd3c43bef4e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 991589
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 640.21(g)Informed consent
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 640.34(b)Fresh Frozen Plasma - storage requirements
- 21 CFR 630.30(b)(2)Unsuitable donation - defer testing
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.65(e)Following manufacturer's instructions
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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 |
| May 17, 2013 | 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 833281 - 2013-05-17
- FDA Inspection 780127 - 2012-05-15
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