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550884

NYU Langone Health, Transplantation & Cellular Therapy — FEI 2470026

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 19, 2008
Fiscal Year
2009
Product Type
Biologics
Project Area
Blood and Blood Products
Location
New York, NY (United States)

Facility

Other inspections at this facility

  • 1274509 (NAI Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1250142 (VAI Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1177868 (NAI Fri Aug 19 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015463 (VAI Thu May 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 922842 (VAI Thu Apr 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
20821 CFR 640.3(a)(1)Donor suitability procedures not followed
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs