666986

American Red Cross Blood Services — FEI 1273014

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 15, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Farmington, CT (United States)

Citations

IDCFRDescription
10005n/aProcedural requirements
3121 CFR 606.20(b)Qualifications of responsible personnel
441321 CFR 211.194(a)(8)Second person sign off
457621 CFR 211.192No written record of investigation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs