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754520

ZOLL Medical Corporation — FEI 1220908

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 15, 2011
Fiscal Year
2012
Product Type
Devices
Project Area
Postmarket Assurance: 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
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
319221 CFR 820.30(g)Design validation - user needs and intended uses
383721 CFR 820.25(b)Training records
425321 CFR 821.25(d)Notification of FDA re: non-compliant distributor