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Actavis, FDA reach consent decree.

Actavis Inc. has reached agreement with the FDA on a Consent Decree of Permanent Injunction the company's Actavis Totowa LLC subsidiary. This agreement, in effect, settles the issues identified by the Department of Justice in its previously filed complaint against Actavis Inc., Actavis Totowa, and officers Sigurdur Oli Olafsson and Douglas Boothe.

The decree only affects operations at Actavis Totowa in NJ. These include two oral-dose manufacturing sites, and one packaging facility. 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 FDA's cGMP and has passed follow-up FDA inspections of the facilities. The company anticipates commercial production at Actavis' Totowa facilities will resume shortly.

"We have been working with the FDA to address compliance issues at the Totowa facilities," said John LaRocca, Actavis Inc.'s chief legal officer. "We have an entirely new management team in place at Little Falls and have invested significantly to reinforce systems and procedures intended to better ensure robust, sustainable compliance. We will continue to work with the FDA to show that we have addressed all of the agency's compliance and manufacturing issues."

Prior to reaching this agreement, Actavis engaged Parexel to assess Actavis Totowa facilities. Parexel has 25 years of experience in helping companies bring safe and effective treatments to the global marketplace. Parexel will continue to work with Actavis Totowa to facilitate ongoing compliance with the consent decree, according to an Actavis statement.

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Title Annotation:INDUSTRY NEWS
Publication:Contract Pharma
Date:Jan 1, 2009
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