Biotronik Gets Warning Letter for Validation, Other Procedures
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.
The FDA also noted a failure to establish and maintain procedures to ensure that sampling methods were adequate. For example, there was no statistical rationale to justify the sampling method used for incoming raw material inspection.
In inspectors found deficiencies in the firm’s medical device reporting procedures. For example, procedures that involved handling complaints did not include a system for transmitting timely reports. The procedures failed to say how adverse events would be documented and reported to ensure access to information that facilitated timely follow-up by the FDA.
In addition, Biotronik failed to establish and maintain procedures to control environmental conditions that affected product quality, and to notify the FDA in a timely manner of a serious device malfunction.
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