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558190

VA New York Harbor Healthcare System — FEI 2470929

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 30, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Blood and Blood Products
Location
New York, NY (United States)

Facility

Other inspections at this facility

  • 1252844 (NAI Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1108230 (NAI Wed Sep 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1005195 (NAI Thu Mar 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 930238 (NAI Mon Jun 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 850938 (VAI Thu Sep 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
135821 CFR 211.100(b)SOPs not followed / documented
441321 CFR 211.194(a)(8)Second person sign off