1023598

Vitalant — FEI 3000210247

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 31, 2017
Fiscal Year
2017
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Denver, CO (United States)

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
15521 CFR 606.160(b)Required records
25521 CFR 640.31Donor eligibility
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations