FDA Inspection 817766 — Vitalant Reference and Transfusion Service

Vitalant Reference and Transfusion Service — FEI 2577618

The FDA completed an inspection of Vitalant Reference and Transfusion Service on February 7, 2013 in Pittsburgh, PA. 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
February 7, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Pittsburgh, PA (United States)

Citations

IDCFRDescription
127021 CFR 211.68(b)input/output verification
15421 CFR 606.160(a)(1)Concurrent documentation