FDA Inspection 737394 — The American National Red Cross - Southern Region

The American National Red Cross - Southern Region — FEI 1073000

The FDA completed an inspection of The American National Red Cross - Southern Region on Jul 22, 2011 in Douglasville, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jul 22, 2011
Fiscal Year
2011
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Douglasville, GA (United States)

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
923521 CFR 630.40(c)Documentation

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