682524

Department of Defense - Navy — FEI 1176560

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 3, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Bethesda, MD (United States)

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
3121 CFR 606.20(b)Qualifications of responsible personnel
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
922521 CFR 606.171Biological product deviation report