FDA Inspection 730626 — New York Blood Center Inc

New York Blood Center Inc — FEI 2170665

The FDA completed an inspection of New York Blood Center Inc on June 17, 2011 in St. Paul, MN. 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 17, 2011
Fiscal Year
2011
Product Type
Biologics
Project Area
Blood and Blood Products
Location
St. Paul, MN (United States)

Citations

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