FDA Inspection
Eastern Colorado Health Care SystemEastern Colorado Health Care System – FDA Inspection, Jun 10, 2010
Record Details
This FDA Inspection record concerns Eastern Colorado Health Care System, with an inspection on June 10, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 10, 2010
- Product Type
- Biologics
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ID · cdd9d59b-5069-465a-bfd7-c9c6b5ac9848
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 667872
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.160(b)Required records
- 21 CFR 211.68(b)input/output verification
- 21 CFR 606.100(b)(10)Controlling storage temperatures
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Eastern Colorado Health Care System
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 29, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 7, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 1, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 16, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 14, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Eastern Colorado Health Care System
- FDA Inspection 1232796 - 2024-02-29
- FDA Inspection 1083599 - 2019-02-07
- FDA Inspection 1019116 - 2017-06-01
- FDA Inspection 920079 - 2015-03-16
- FDA Inspection 813939 - 2013-01-14
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