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FDA Gains Attention Of Boston Scientific Execs With Corporate Warning Letter

This article was originally published in The Silver Sheet

Executive Summary

WHILE BOSTON SCIENTIFIC’S RECENT FDA CORPORATE WARNING LETTER may be seen as a rocky start to 2006 for the medical device industry, statistics show that the overall number of standard warning letters issued by the agency actually dropped 9% in 2005. FDA officials are guardedly hopeful that Boston Scientific – which recently sent a response to the agency – will be able to quickly rectify its various corporate-wide quality systems violations. As for standard warning letters sent to firms last year, CAPA once again was the most frequently violated Quality System Regulation requirement, while management responsibility citations dipped significantly. FDA Quality Systems Expert Kim Trautman announces an upcoming change to CDRH’s Level I inspection program; the new approach promises to reduce the number of unnecessary management responsibility observations by agency investigators on FDA 483 forms and warning letters... COMPLETE LISTING of QS warning letters released in 2005 includes several leading firms...
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