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Warning Letter

Case 500732 — FEI 3002806500

Facility

Recent inspections

  • 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))
  • 742999 (VAI Thu Aug 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 597351 (NAI Thu Jul 02 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Biotronik SE & Co. KG
Date
September 1, 2016
Fiscal Year
2016
Product Type
Devices
Center
CDRH
Location
Berlin (Germany)