FDA Inspection
Children's Hospital Colorado, Blood bankChildren's Hospital Colorado, Blood bank – FDA Inspection, May 15, 2012
Record Details
This FDA Inspection record concerns Children's Hospital Colorado, Blood bank, with an inspection on May 15, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 15, 2012
- Product Type
- Biologics
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ID · 33888a8a-56ec-458f-b99b-38efab4a0590
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 780127
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
11- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.140(c)Adequate identification and handling of test samples
- 21 CFR 640.3(a)Donor suitability by means of medical history
- 21 CFR 630.40(c)Documentation
- 21 CFR 606.140(a)Establishment of spec., standards, and test procedures
- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)(21)Donor notification
- 21 CFR 606.100(b)(10)Controlling storage temperatures
Showing 10 of 11 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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