FDA Inspection 973820 — The American National Red Cross

The American National Red Cross — FEI 1276528

The FDA completed an inspection of The American National Red Cross on Jun 3, 2016 in Worcester, MA. 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). 2 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jun 3, 2016
Fiscal Year
2016
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Worcester, MA (United States)

Citations

IDCFRDescription
6721 CFR 606.65(e)Following manufacturer's instructions
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs

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