Ranbaxy did not heed the warnings issued by consulting firms and independent auditors over the quality of its procedures, control, systems and data documentation years before running into trouble with the FDA, this article says. Ranbaxy's senior management overlooked a warning in October 2003 regarding the inconsistencies in its source data, as well as the fact that required training for current good manufacturing practices was "essentially non-existent," documents show. Ranbaxy also failed to act after it was warned about falsifying data and other illegal practices in 2004, the article says. Ranbaxy settled charges this month of manufacturing malpractice and data manipulation with U.S. regulators for $500 million.
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