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.