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1209368

New York Blood Center Enterprises — FEI 2473015

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 6, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Rye, NY (United States)

Facility

Other inspections at this facility

  • 1283668 (VAI Wed Sep 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1217513 (NAI Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1168524 (NAI Thu Apr 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118178 (VAI Tue Feb 11 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064704 (NAI Tue Aug 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
6721 CFR 606.65(e)Following manufacturer's instructions
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
907821 CFR 600.12(a)Maintenance - tracing
908921 CFR 600.14(c)When to report
9821 CFR 606.100(c)Thorough investigations