WASHINGTON (AP) -- Generic drugmaker Actavis has agreed to shut down several plants in New Jersey until they meet U.S. quality standards for the testing and manufacturing of pharmaceuticals.
The Food and Drug Administration said Friday it has filed a consent decree which will bar Actavis Totowa from making or distributing drugs from its plants in Totowa and Little Falls, N.J.
Under the agreement, executives Sigurdur Olafsson and Douglas Boothe will be able to resume production only after FDA confirms the plants meet U.S. regulatory standards.
The agreement also allows FDA to shut down the plants again if violations continue, and to fine the company $15,000 per day thereafter, up to $7 million per year.
FDA said it filed the action against Actavis Dec. 23 in U.S. District Court of New Jersey, and is awaiting a permanent injunction against the company.
Actavis Inc. and Actavis Totowa LLC are units of Iceland-based Actavis Group.
In April, Actavis recalled its generic heart drug Digitek because some tablets may have been twice as thick as they were supposed to be, which would have doubled the dose and created a greater risk of side effects.
In inspections last spring, the FDA found the company kept incomplete lab records of its testing data, and failed to verify that its testing methods matched up with actual conditions under which the products would be used. The company also made drugs at the Little Falls facility that had not been approved by the FDA.
"The FDA will not allow manufacturers to put the public's health at risk," FDA drug center chief Janet Woodcock said in a statement. "These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks."
The federal Department of Justice filed its initial lawsuit against the company in November.
