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1203742

North Shore University Hospital Northwell Health — FEI 2475795

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 26, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Manhasset, NY (United States)

Facility

Other inspections at this facility

  • 1241373 (NAI Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1174916 (VAI Wed Jul 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1120549 (VAI Thu Mar 12 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1095201 (NAI Thu Jun 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1030808 (NAI Mon Oct 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
908621 CFR 600.14(a)(1)Who must report - manufacturer