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Later this year, FDA expects to complete initial inspections of every facility that manufactures drugs for the US market. As the agency visits under-the-radar facilities recently targeted as part of an effort to leave no site uninspected, it is finding that they are more likely to have serious drug GMP issues.
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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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