787546

The American National Red Cross - Southern Region — FEI 1073000

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 29, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Douglasville, GA (United States)

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
22421 CFR 640.4(f)Arm preparation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9421 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration