FDAnews Device Daily Bulletin

Biotronik Gets Warning Letter For Validation, Other Procedures

Feb. 14, 2017

Germany’s Biotronik received a warning letter for inadequate process validation procedures, supplier selection procedures, and other violations.

Biotronik makes catheters, coronary guide wires, implantable pacemakers, and implantable cardioverter defibrillators. Following a March 2016 inspection of the company’s facility in Berlin, the FDA found the company had failed to adequately validate a process that could not be fully verified by subsequent testing. Specifically, the company did not properly validate the method used to coat Selectra catheter leads.

The company was also cited for failing to adequately evaluate potential suppliers based on their ability to meet quality and other requirements. Biotronik’s procedure required evaluations to be documented before suppliers were chosen, but there was no documentation for the supplier evaluations for the Selectra catheter. — Jeff Kinney

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