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Despite Globalization, Three Quarters of Serious Issues FDA Found Were in US

This article was originally published in The Gold Sheet

Executive Summary

FDA inspection results data show that even as the agency responded to the threat of poor drug quality abroad in fiscal years 2009-2014, it was more successful at finding serious quality issues during its much more numerous domestic inspections. Asian inspections were somewhat more likely to identify serious issues than US ones, while European inspections were much less likely to raise any, and neither identified nearly as many.


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