FDA Inspection 1096443 — The American National Red Cross

The American National Red Cross — FEI 3072996

The FDA completed an inspection of The American National Red Cross on June 27, 2019 in Portland, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 27, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Portland, OR (United States)

Citations

IDCFRDescription
1813421 CFR 640.21(g)Informed consent
27421 CFR 640.34(c)Liquid Plasma - storage requirements