Processing Magazine

Attorneys move to close Actavis NJ facilities

November 17, 2008

The Associated Press reports that U.S. Attorneys in New Jersey have filed a lawsuit seeking a shutdown of three Actavis Inc. plants until they are brought into compliance with testing, manufacturing laws and FDA regulations. The complaint requests that the court prevent Actavis Inc., Actavis Totowa, and executives from being involved in the making of drugs until the company is brought into compliance with Food and Drug Administration requirements for testing, quality control and test response, and ceases selling unapproved and misbranded drugs. The suit states that since early 2006, Actavis'' facilities in Totowa and Little Falls, N.J. have repeatedly failed inspections by the FDA, the company has not made the necessary improvements. Actavis Inc. and Actavis Totowa LLC are units of Iceland-based Actavis Group. In a press release, Actavis said the company has focused on complying with the FDA since May and believes it will meet and exceed the agency''s requirements. The company said it invited FDA inspectors back to its facilities in October, but so far, the agency has not made a return visit. The FDA investigated the two facilities in Totowa and one in Little Falls a total of five times between January 2006 and May 2008. In April, Actavis recalled its 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. The drug was sold under different names by Mylan Inc. and UDL Laboratories Inc. In the inspections, 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. It also did not investigate unusual test results, didn''t follow its own stability testing procedures, and didn''t make sure test samples met its specifications. Further, the FDA said Actavis'' quality control unit didn''t follow its written procedures and check that all issues were resolved before the drugs were sold. The violations continued in further inspections. The company also made drugs in the Little Falls facility that had not been approved by the FDA, according to the suit.