878427

AdventHealth Parker — FEI 3007588139

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 15, 2014
Fiscal Year
2014
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Parker, CO (United States)

Citations

IDCFRDescription
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations