DOJ Files Complaint Against Actavis

Tthe Department of Justice, on behalf of the FDA, has filed a complaint seeking a permanent injunction against Actavis Totowa LLC, a Morristown, NJ-based subsidiary of Actavis Inc.

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, 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.”

On April 25, 2008, Actavis Totowa LLC initiated a Class 1 nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use. The products, manufactured by Actavis, are distributed by Mylan Pharmaceuticals, Inc. under the “Bertek” label and by UDL Laboratories, Inc. under the “UDL” label.

The recall followed an inspection conducted by the Food and Drug Administration that revealed operations at the Little Falls, NJ, facility which did not meet the FDA’s or Actavis’ standards for good manufacturing practices.

On August 1, the company initiated a precautionary, voluntary recall—to the retail level—of all drug products manufactured at its Little Falls facility.

SOURCE: Business Wire