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FDAnews Device Daily Bulletin
June 27, 2012 | Vol. 9 No. 126
Experts: Companies Facing Warnings Must Dig Deep for Root Causes
Companies who react to a warning letter simply by fixing the immediate problems may put themselves at risk for future incidents, experts said last month at the FDA/Xavier University MedCon Conference. FDA warning letters and Form 483s simply document observations made at one moment in time, Steve Niedelman, lead quality system and compliance consultant with law firm King & Spaulding and a former FDA compliance officer, stressed during a panel discussion.
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