FDA Inspection
UC Health Poudre Valley HospitalUC Health Poudre Valley Hospital – FDA Inspection, Aug 19, 2010
Record Details
This FDA Inspection record concerns UC Health Poudre Valley Hospital, with an inspection on August 19, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 19, 2010
- Product Type
- Biologics
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ID · 2e6f5202-9d39-4aaf-a6b2-3953a1c70a10
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 678411
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 606.160(e)(1)Donor deferral record - each location
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of UC Health Poudre Valley Hospital
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2026 | Not classified | Denver District Office | Blood and Blood Products |
| June 5, 2025 | VAI | Denver District Office | Blood and Blood Products |
| September 14, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 15, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 30, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for UC Health Poudre Valley Hospital
- FDA Inspection 1330216 - 2026-07-16
- FDA Inspection 1271896 - 2025-06-05
- FDA Inspection 1130281 - 2020-09-14
- FDA Inspection 1042702 - 2017-11-15
- FDA Inspection 952024 - 2015-11-30
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