681143

American National Red Cross - Johnstown, PA — FEI 2573016

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 24, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Johnstown, PA (United States)

Citations

IDCFRDescription
10005n/aProcedural requirements
1220221 CFR 606.170(a)Adverse Reaction - Investigations
3121 CFR 606.20(b)Qualifications of responsible personnel
357021 CFR 211.100(a)Approval and review of procedures
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs