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US FDA’s New Compliance Chief Donald Ashley Brings International Law Enforcement Experience

Executive Summary

Ashley's many years in the Department of Justice’s Office of International Affairs should be a plus for agency's globalization efforts.

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US FDA Crossing Off More Foreign OTC Firms On Globalization Checklist

FDA issued 39 warning letters to OTC drug facilities, most of them outside the US, in 2017, a number significantly boosted by an initiative to inspect a total of 1,000 foreign drug manufacturers from January 2017 through September 2019 , says CDER compliance director Donald Ashley. Many GMP violations behind FDA's warning letters concerned “rudimentary" requirements.

US FDA Crossing Off More Foreign OTC Firms On Globalization Checklist

FDA issued 39 warning letters to OTC drug facilities, most of them outside the US, in 2017, a number significantly boosted by an initiative to inspect a total of 1,000 foreign drug manufacturers from January 2017 through September 2019 , says CDER compliance director Donald Ashley. Many GMP violations behind FDA's warning letters concerned “rudimentary" requirements.

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Poor data integrity at Asian API firms, poor quality programs at foreign OTC firms and poor sterility assurance at US compounding pharmacies were the main factors leading US FDA to issue 110 drug GMP warning letters in 2016, a huge increase from prior years. Article is first of four-part series in our annual analysis.

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