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.
You may also be interested in...
Indian CEOs On Plugging Quality Gaps: Yes We Can
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 Mutual Reliance with EU on Inspections Is Slow Going
FDA still does over 40% of its inspections in Europe even as it acknowledges it must spend the money elsewhere.
Hamburg Promises Quicker Enforcement as FDA Spews Warning Letters
Hair-trigger enforcement seen as FDA sends in U.S. Marshals and negotiates consent decrees in cases without even first issuing warning letters. The agency is pushing more redacted Form 483 reports onto the web, while the second quarter warning letter rate is back up to Clinton administration levels. Meanwhile, Commissioner Hamburg announces six initiatives to expedite enforcement. Chief among them is a decision to limit Office of Chief Counsel reviews of warning letters. Another is a time clock on Form 483 responses. Additional measures would strengthen ties with other countries' enforcement agencies and establish quicker follow-up and closeout of enforcement cases. Caraco, Clarcon and Teva Animal Health quick-response cases described.