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 2016Roy Baby FDA$119.00 - Available Now
FDA investigators audited the Biotronik SE & KG - Berlin, Germany facility and issued 6 inspectional observations (via FDA 483) on 10 Mar 2016.
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- Category: Medical Devices & Rad Health
- Number of Observations: 6
- Inspection end: 10 Mar 2016
- Location: Berlin, Germany
- FEI: 3002806500