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DT: Until about two years ago, inspectors from the U.S. FDA informed companies like Ranbaxy months ahead of time before they went to India to inspect their manufacturing facilities. This gave companies like Ranbaxy adequate notice in order to prepare for a regulatory inspection. Most inspectors were from the U.S. so they did not understand the Indian culture. Cultural and language barriers did not help. Manufacturing facilities are located in rural India; the company representatives often accompanied inspectors from the U.S. FDA to these remote locations. So the odds were always in the favor of the company, and it could rig the inspection so that the results would come out in their favor.
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