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Ranbaxy Unit Gets FDA Warning Letter

by Jean-François Tremblay
January 11, 2010 | A version of this story appeared in Volume 88, Issue 2

FDA has sent a warning letter to Ohm Laboratories for not complying with current Good Manufacturing Practices. Based in North Brunswick, N.J., Ohm is a U.S. subsidiary of Ranbaxy Laboratories that produces liquid generic medications. Ranbaxy says it has hired the consulting firm PRTM to fix the latest problems that FDA found. Ranbaxy has had repeated run-ins with U.S. regulators in recent years. In July 2008, the Department of Justice said it would investigate whether the firm had falsified data for drugs manufactured at an Indian facility until 2006. Then, in September 2008, FDA banned drugs that the company makes at two plants in India.

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