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St Jude warning letter highlights quality systemfailures

This article was originally published in Clinica

Executive Summary

St Jude Medical has received a warning letter from the US FDA highlighting production quality issues at its Minnetonka, Minnesota facility for manufacturing ablation catheters. The letter, dated April 17, is a result of an FDA inspection that took place in December 2008 where the FDA found a number of faults with manufacturing processes related to the firm’s Safire ablation catheter. The FDA said that it had received responses from the St Paul, Minnesota firm addressing some of these issues in January, February and April this year, but stated that “several of the corrective actions have not been completed”. Any applications made by the firm for premarket approval of class III devices will not be granted until the violations have been resolved.

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