Decree outlines path to move forward on manufacturing at Totowa facilities

Actavis Inc. today announced that it has reached agreement on a Consent Decree of Permanent Injunction with the Food and Drug Administration (FDA) regarding 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 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 FDA’s current good manufacturing practice (cGMP) and has passed follow-up FDA inspections of the facilities. The company anticipates that commercial production in the 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. 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.”

Prior to reaching this agreement, Actavis engaged PAREXEL, a well regarded outside firm, 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.

Editor’s Note:
The Totowa facilities affected by this Consent Decree are located in New Jersey. Two of these facilities (“Little Falls” and “Riverview”) are oral-dose manufacturing sites, and one (“Taft”) is a packaging facility.

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