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544732

Mount Sinai Hospital Blood Bank — FEI 2470025

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 18, 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

  • 1243297 (VAI Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
311721 CFR 820.70(i)Software validation for automated processes
323121 CFR 820.70(i)Documentation of software validation
343221 CFR 820.75(b)(2)Documentation of validated process performance
357021 CFR 211.100(a)Approval and review of procedures
368421 CFR 820.75(a)Documentation - specific items
7521 CFR 606.100(a)SOP compliance
923621 CFR 630.40(b)(1)Deferred or not eligible