2008 DEC 8 -- Actavis, Inc. said that the Department of Justice, on behalf of the Food and Drug Administration (FDA), has filed a complaint seeking a permanent injunction against the business of its Actavis Totowa LLC subsidiary.
The filing comes as the company continues to work to address compliance issues stemming from an inspection of the Actavis Totowa facilities by the FDA earlier this year. Since May 2008, the company has focused entirely on ensuring the quality and integrity of its manufacturing and quality systems.
Actavis remains confident that the actions it has taken to remedy the compliance and manufacturing issues at Actavis Totowa will exceed FDA's expectations and will more accurately represent Actavis standards for good manufacturing practices than what FDA previously observed. The company views the filing of this complaint as one step in a long regulatory process, and is fully committed to working collaboratively and openly with the FDA in a timely manner.
"We have taken a comprehensive approach to correcting all deficiencies within the Totowa business, and we've communicated regularly and candidly with the FDA, the public, our employees and our customers," said John LaRocca, Actavis Inc.'s Chief Legal Officer. "Last month, we asked FDA to return to the Totowa facilities, conduct an inspection, and observe the substantial progress we have made. To this point, the FDA has not acted. Our company takes these matters very seriously, and we remain focused on quality, innovation and product safety. We look forward to a quick and satisfactory resolution to these issues for the benefit of consumers, the agency and ourselves."
Keywords: Actavis, Inc., FDA, Regulatory Actions, U.S. Food and Drug Administration
This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2008, Biotech Business Week via NewsRx.com.
