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Facility noncompliance in US drops to 2009 levels

This article was originally published in Clinica

Executive Summary

Medical device Form 483s – documents that US FDA inspectors issue to companies to indicate areas of noncompliance at facilities – dropped in fiscal 2014 for the first time in six years. The number issued for medical devices in FY2014 (year to 30 September 2014) was 972, a drop of 11.6% on the FY2013 total of 1,099. The last time that medical device 483s were at a similar level was in FY2010.

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