FDA Inspection 916155 — 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 March 16, 2015 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
March 16, 2015
Fiscal Year
2015
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