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919320

North Shore University Hospital Northwell Health — FEI 2475795

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 20, 2015
Fiscal Year
2015
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))
  • 1203742 (VAI Wed Apr 26 2023 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))

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
15521 CFR 606.160(b)Required records
22421 CFR 640.4(f)Arm preparation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs