FDA Inspection 1327194 — New York Blood Center, Inc.

New York Blood Center, Inc. — FEI 3002663381

The FDA completed an inspection of New York Blood Center, Inc. on Jul 17, 2026 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jul 17, 2026
Fiscal Year
2026
Product Type
Biologics
Project Area
Blood and Blood Products
Location
New York, NY (United States)

Citations

IDCFRDescription
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
7721 CFR 606.100(b)Written SOPs available for use by personnel