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

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.

Despite a steady drumbeat of criticism about foreign manufacturing quality and a risk-based focus on foreign sites, nearly three quarters of all serious quality lapses that FDA found in fiscal years 2009-2014 were in the US.

This was not only because FDA inspected more US sites – it was also because those sites were slightly more likely to have serious problems than foreign sites, according to...

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