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729955

ZOLL Medical Corporation — FEI 1220908

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 7, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: Devices
Location
Chelmsford, MA (United States)

Facility

Other inspections at this facility

  • 992399 (VAI Tue Oct 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 982649 (NAI Fri Aug 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 966609 (NAI Fri Apr 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 900180 (NAI Thu Aug 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 875284 (VAI Fri Apr 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
310421 CFR 820.30(j)Design history file
313021 CFR 820.100(a)Lack of or inadequate procedures
424821 CFR 821.25(b)Records not current
425221 CFR 821.25(c)(3)Quality assurance procedures: 6-month & annual audits
53921 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.