FDA Inspection 1037762 — New York Blood Center Enterprises

New York Blood Center Enterprises — FEI 3003490413

The FDA completed an inspection of New York Blood Center Enterprises on January 16, 2018 in Melville, 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 16, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Melville, NY (United States)

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
6121 CFR 606.60(a)Provide proper equipment to meet requirements