FDA Inspection 740373 — Upstate New York Transplant Services Inc

Upstate New York Transplant Services Inc — FEI 3000718051

The FDA completed an inspection of Upstate New York Transplant Services Inc on August 5, 2011 in Williamsville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 5, 2011
Fiscal Year
2011
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Williamsville, NY (United States)

Citations

IDCFRDescription
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs