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947800

Health Network Laboratories-Pocono — FEI 2573926

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 10, 2015
Fiscal Year
2016
Product Type
Biologics
Project Area
Blood and Blood Products
Location
East Stroudsburg, PA (United States)

Facility

Other inspections at this facility

  • 1020349 (VAI Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 861764 (NAI Fri Jan 10 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 778733 (NAI Wed Apr 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 675180 (NAI Mon Aug 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
16521 CFR 606.170(a)Adverse reaction - Maintenance of Reports
8821 CFR 606.100(b)(9)Written methods for investigating adverse reactions
9421 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration