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1243297

Mount Sinai Hospital Blood Bank — FEI 2470025

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 2, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Blood and Blood Products
Location
New York, NY (United States)

Facility

Other inspections at this facility

  • 1168200 (NAI Wed Apr 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046035 (NAI Wed Jan 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 950522 (NAI Thu Nov 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 889365 (NAI Mon Jul 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 762012 (NAI Fri Jan 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
15521 CFR 606.160(b)Required records
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs