FDA issued a Warning Letter to Biotronik SE & Co. KG on 9/1/2016 as a result of this inspection.
483 Biotronik SE & KG Mar 2016

483 Biotronik SE & KG Mar 2016

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FDA investigators audited the Biotronik SE & KG - Berlin, Germany facility and issued 6 inspectional observations (via FDA 483) on 10 Mar 2016.

Product details

  • Category: Medical Devices & Rad Health
  • Number of Observations: 6
  • Inspection end: 10 Mar 2016
  • Location: Berlin, Germany
  • FEI: 3002806500
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