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As Purchasing Controls Become an FDA Hot Topic, It’s Time to Assess How Well You Are Managing Your Suppliers

May 2009

Journal of Medical Device Regulation
This article focuses on the Purchasing Control provisions of the FDA's Quality System Regulation (QSR); recent developments regarding enforcement of those requirements; international guidance aimed at helping manufacturers exercise appropriate control over third-party suppliers; and tips to ensure compliance with FDA's Purchasing Control requirements.


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