Feds scrutinize generic maker.
by Anderson, Jane
India's Ranbaxy Inc., 1 of the top 10 generic drug makers in
the world, is being investigated by various arms of the federal
government for allegedly introducing "adulterated or misbranded
products" into the U.S. market. The company's auditor, Parexel
Consulting, is also under scrutiny. According to a subpoena for
documents filed in the U.S. District Court for the District of Maryland
by the federal Department of Justice and the U.S. Attorney's Office
in Maryland, Ranbaxy submitted false information to the Food and Drug
Administration on sterility and bioequivalence, covered up violations of
good manufacturing practice, and defrauded Medicare. "If these
allegations are true, Ranbaxy has imperiled the safety of Americans in a
manner similar to the generic drug scandal we uncovered 20 years
ago," said Rep. John Dingell (D-Mich.). "I would like to know
whether FDA officials knew about these allegations and what, if any,
action was taken."
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