952024

UC Health Poudre Valley Hospital — FEI 1772751

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 30, 2015
Fiscal Year
2016
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Fort Collins, CO (United States)

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
20521 CFR 640.3(f)Donations in less than eight weeks
20821 CFR 640.3(a)(1)Donor suitability procedures not followed
23821 CFR 640.11(a)General requirements - storage
324521 CFR 640.61Explanation of hazards
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs