The fees charged by outsourced companies for inspections can be high as well due to the small number of FDA approved inspectors, and thus when looking at a potential inspection charge, some of the drug and device manufacturers just wait until the FDA comes around, and it also leaves the door open for perhaps some not so good business practices. Right now there is not much choice other than to rely on outside resources for inspections and as the the article states, “it cannot be business as usual”. The medical device area is even a bit more clouded as it took 2 years to approve the first private contracted inspectors. BD
WASHINGTON, June 12 (Reuters) - U.S. health officials are pushing a plan to allow outside inspectors to monitor the safety of imported pharmaceutical ingredients, but a similar program to inspect foreign-made medical devices has largely floundered. On Monday, U.S. Food and Drug Administration Commissioner Andrew von Eschenbach requested an extra $275 million for the agency's 2009 budget, in part to allow quicker entry for imports certified by private parties. He also called on Congress to allow the FDA to more broadly use inspections done by independent, third parties.
While nearly 80 percent of ingredients used in U.S. prescriptions come from China and India, according to the FDA, in 2007 just 83 plants in those countries were inspected.
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