Despite Globalization, Three Quarters of Serious Issues FDA Found Were in US
This article was originally published in The Gold Sheet
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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The leaders of six leading Indian firms were unequivocal that there is room for improvement on the quality front at a recent conference in Mumbai, but they also emphasized senior management engagement and resolve to get a "quality movement" going in their respective firms and in the domestic industry, in general.
FDA still does over 40% of its inspections in Europe even as it acknowledges it must spend the money elsewhere.