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716766

VA New York Harbor Healthcare System — FEI 2470929

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 5, 2011
Fiscal Year
2011
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
311821 CFR 820.75(a)Documentation
311921 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces