House Demands More Info On FDA Overseas Operations
Executive Summary
GAO to report on foreign office closures and risk-based inspection policy amid concerns that unequal playing field remains.
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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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