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Warning Letter Roundup & Recap

This article was originally published in The Silver Sheet

Executive Summary

bioMérieux closed nearly nineteen thousand complaints without conducting thorough investigations; Cook scrapped more than half a million devices between 2012 and 2014 – but didn’t use that information as a source of CAPA quality data. Eight quality-related warning letters were listed by FDA from Oct. 15 through Nov. 11.

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