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FDA Foreign Inspections On the Rise


Posted in China by Chris Wiltz on September 12, 2013

 FDA is increasing its foreign staff as inspections in India and China have risen dramatically the past 5 years.


 By Jim Dickinson

FDA inspections in China have increased almost three-fold since 2007.
FDA foreign inspections are on the rise, according to agency officials. For example, inspections in India jumped 21% in 2012 compared to the year before, officials from FDA’s Office of International Programs told the Alliance for a Stronger FDA. The number of inspections in India increased to 268 in 2012, up from 221 the year before. FDA’s India office performed about a quarter of the inspections, the officials say. The officials say that so far FDA has the largest number of U.S. government employees in India. Currently the India office houses six medical product inspectors, two food inspectors, and three policy analysts. The office expects to have 19 full-time employees when it is fully staffed.
 
In China, FDA previously conducted about 70 inspections per year in fiscal years 2007 and 2008, but that number has soared almost three-fold to about 190 per year after setting up the agency’s new China office. Despite an allotment in a $10 million budget increase in March, FDA hit a bump in the road in China with obtaining visas for additional inspectors because the staff are credentialed as foreign diplomats and FDA must work through the U.S. embassy to formally submit the number and type of positions it wishes to fill. FDA China Office director Chris Hickey told the Alliance the visa issue is being addressed at the highest levels of government and said that in the meantime FDA is sending inspectors on shorter stints to China.

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