FDA seeks closure of Actavis facilities for producing unapproved drugs

ROCKVILLE, Md. The Food and Drug Administration on Friday announced that it is awaiting the court entry of a permanent injunction against Actavis Totowa, following the filing of a Consent Decree on Dec. 23.

FDA is seeking to shut down three Actavis manufacturing facilities for not complying with good manufacturing practice requirements, stating that the drugs manufactured in those facilities are unapproved drugs. “The injunction will remain in effect until Actavis Totowa comes into compliance with U.S. current Good Manufacturing Practice  requirements, and obtains FDA’s approval to manufacture and distribute drugs in the United States,” the agency said.

“The FDA will not allow manufacturers to put the public’s health at risk,” Janet Woodcock, director, Center for Drug Evaluation and Research, FDA said. “These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.”

Actavis signed a consent decree that permits them to resume operations with respect to three categories of drugs only after an expert certifies that the drugs comply with the CGMP requirements and have FDA approval, and FDA inspects to confirm compliance with the law. The consent decree also requires defendants to destroy any remaining drugs that they recalled in April-July 2008, that are currently in their possession.

FDA advised patients who have been using Actavis products to discuss alternative therapies with their healthcare provider. Pharmacists should discontinue dispensing all unapproved drugs manufactured by Actavis Totowa, the agency added.

The consent decree also authorizes FDA to order the defendants to cease operations in the event of future violations. It further subjects the defendants to liquidated damages of $15,000 per day if they fail to comply with any of the provisions of the decree, and to the payment of an additional $15,000 for each violation, up to $7 million per year.

Actavis Totowa manufactures, processes, packages, labels, holds, and distributes drugs from two sites in Totowa, N.J., and one in Little Falls, N.J. FDA inspected Actavis Totowa’s Riverview Drive facility in Totowa from March-May 2008, and found that the company had significant cGMP violations and continued to manufacture unapproved drugs. As a result of this inspection, Actavis Totowa recalled all products manufactured and distributed from its three facilities. Actavis Totowa is a wholly owned subsidiary of Actavis, the manufacturing and marketing arm of Actavis Group, a generic pharmaceutical company based in Reykjavik, Iceland.

“The FDA will carefully monitor the provisions of this injunction to ensure compliance, said Michael Chappell, FDA acting associate commissioner, Office of Regulatory Affairs. “Companies should know that FDA will investigate and take action against other marketers of unapproved drugs.”