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news.Actavis, a generic pharmaceutical company, has reached an agreement on a consent decree of permanent injunction with the FDA regarding the company's Actavis Totowa subsidiary.
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This agreement, in effect, settles the issues identified by the Department of Justice in its previously filed complaint against the company, Actavis Totowa, and officers Sigurdur Olafsson and Douglas Boothe.
The consent decree only affects operations at Actavis Totowa in New Jersey. Pursuant to the consent decree, Actavis has agreed to not distribute any products from the Actavis Totowa facilities until it has certified completion of certain enumerated requirements that demonstrate compliance with the FDA’s current good manufacturing practice and has passed follow-up FDA inspections of the facilities. The company anticipates that commercial production in the Actavis Totowa facilities will resume shortly.
Prior to reaching this agreement, Actavis engaged Parexel, a biopharmaceutical services company, to assess Actavis Totowa facilities. Parexel is expected to continue to work with Actavis Totowa to facilitate ongoing compliance with the consent decree.
John LaRocca, chief legal officer of Actavis, said: This agreement with the agency is a positive step and is one we have looked forward to reaching. We will continue to work with the FDA to show that we have addressed all of the agency’s compliance and manufacturing issues.