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742999

Biotronik SE & Co. KG — FEI 3002806500

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 18, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Berlin (Germany)

Facility

Other inspections at this facility

  • 1022011 (NAI Thu Jun 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 965124 (OAI Thu Mar 10 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 847640 (VAI Tue Aug 13 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 597351 (NAI Thu Jul 02 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
53921 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.