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Pharmaceuticals / Quality / Inspections and Audits

FDA Warning Letters to Foreign Facilities Soar in 2017

March 31, 2017
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FDA warning letters to foreign drug and API manufacturing facilities have increased more than tenfold so far this year compared to the same period in 2016.

Of the 20 warning letters the agency issued for GMP violations in January and February, 11 went to  overseas facilities, including five in China, two in India,  two in Japan, one in the United Kingdom and one in Italy.

The agency is paying more attention to facilities in China in 2017. India was consistently the most-cited foreign country in the past two years, but has fallen to second place.

Testing and data integrity issues are frequently cited in the warnings. For example, FDA warned China-based API manufacturer Chongqing for using incomplete and manipulated data as its basis for decisions on batch releases.

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