December 30, 2014

FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for the Fiscal Year 2014 – In our last FDA FastStats series of the year, we look back at all FDA 483 Inspectional Observations for the Fiscal Year 2014. 483s increased in foods from the prior fiscal year to 2476, an increase of 3.8%. However, medical devices and drugs were down -11.6% and -6.5%, respectively, from FY 2013. Interestingly, medical device 483s bucked their recent upward trend with the lowest number of observations since FY 2009.

FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014

 

About AssurX:

With decades of expertise built into our quality management and regulatory compliance software platform, AssurX helps companies maintain quality and compliance, streamline workflow, control risks, and better manage your enterprise. Our configurable software and deep understanding of users’ needs produce a unique system that easily adapts as your business evolves.

AssurX is an ideal partner for regulated companies looking for better operational control and efficiency while meeting and exceeding compliance standards.

 

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