FDA Inspection 1226814 — U.S. Dept. of Veterans Affairs, Northport VA Medical Center

U.S. Dept. of Veterans Affairs, Northport VA Medical Center — FEI 2470925

The FDA completed an inspection of U.S. Dept. of Veterans Affairs, Northport VA Medical Center on January 9, 2024 in Northport, NY. 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
January 9, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Northport, NY (United States)

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs