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967291

Nassau Health Care Corporation d/b/a/ NuHealth — FEI 2473605

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 8, 2016
Fiscal Year
2016
Product Type
Biologics
Project Area
Blood and Blood Products
Location
East Meadow, NY (United States)

Facility

Other inspections at this facility

  • 1179788 (VAI Mon Sep 19 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1042421 (VAI Thu Feb 22 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 856795 (VAI Mon Nov 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 749273 (VAI Wed Oct 05 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 645399 (VAI Tue Feb 16 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
15921 CFR 606.160(a)(1)Legibility and indelibility
180921 CFR 211.160(a)Following/documenting laboratory controls
904421 CFR 600.10(b)Personnel capabilities
905021 CFR 600.11(a)Work areas
907821 CFR 600.12(a)Maintenance - tracing
922521 CFR 606.171Biological product deviation report
923421 CFR 630.40(c)Notification w/in 8 weeks
9821 CFR 606.100(c)Thorough investigations