FDA Inspection
Medical Center of the RockiesMedical Center of the Rockies – FDA Inspection, Jan 16, 2014
Record Details
This FDA Inspection record concerns Medical Center of the Rockies, with an inspection on January 16, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 16, 2014
- Product Type
- Biologics
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ID · a80affb7-061d-4fba-9ae5-b926518f1f55
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 860554
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Medical Center of the Rockies
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 10, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 13, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 30, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 3, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 1, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Medical Center of the Rockies
- FDA Inspection 1312526 - 2026-04-10
- FDA Inspection 1195640 - 2023-01-13
- FDA Inspection 1035282 - 2017-11-30
- FDA Inspection 952025 - 2015-12-03
- FDA Inspection 752183 - 2011-11-01
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