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800735

Zoll Medical Corporation — FEI 2112020

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 18, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Deerfield, WI (United States)

Facility

Other inspections at this facility

  • 1171958 (VAI Mon Jun 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 712206 (NAI Tue Jan 11 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 683406 (VAI Fri Dec 17 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 619666 (OAI Thu Oct 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
265021 CFR 820.30(f)Design verification - Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
337221 CFR 820.198(d)Records of MDR Investigation