FDA Awaits Court's Entry of A Permanent Injunction Against Actavis Totowa, LLC
Fri, 09 Jan 2009 10:25:00 -0600
The U.S. Food and Drug Administration announced that it had filed a Consent Decree on December 23, 2008, and currently awaits the court's entry of a permanent injunction that bars Actavis Totowa, LLC, Actavis, Inc., and their officers, Sigurdur Oli Olafsson and Douglas Boothe, from manufacturing and distributing drugs at the Actavis Totowa facilities. The injunction will remain in effect until Actavis Totowa comes into compliance with U.S. current Good Manufacturing Practice (cGMP) requirements, and obtains FDA's approval to manufacture and distribute drugs in the United States. The companies and their officers had also been manufacturing and distributing unapproved drugs in the United States.
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