Management Inattention Is Root Cause Of Many QS Compliance Problems
This article was originally published in The Silver Sheet
ANNUAL QUALITY SYSTEM WARNING LETTER ANALYSIS finds the number of letters rising to previous norms, with 108 issued in 2004. CDRH Office of Compliance Director Ulatowski has sharp words for device company execs who are remiss in their duty to ensure manufacturing quality, saying it is often "extremely apparent they don’t understand what their obligations are" under the Quality System reg. CAPA, management responsibility and complaint handling are the top three citation areas
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