Feds Turn Up the Heat on Iceland's Actavis Generic-Manufacturing Plants in New Jersey

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Reported by Annette Kreuger, Industrial Info Resources (Sugar Land, Texas)--Both the Food and Drug Administration (FDA) and the Department of Justice are scrutinizing the Actavis Group (Iceland) and its generic-manufacturing operations in New Jersey. Earlier this month, U.S. attorneys in New Jersey filed a lawsuit to shut down the company's plants in Totowa and Little Falls until the sites are brought into full compliance with the law. According to authorities, the plants have repeatedly failed FDA inspections dating back to 2006. Allegations against the company include keeping incomplete testing lab data, the investigation of unusual product test results and noncompliance with the confirmation that product test samples met specifications.

In April of this year, in an action considered the most serious, the FDA issued a Class I recall of Digitek, the Actavis brand of the cardiac drug digoxin. The action ensued when tests revealed the drug, which is produced at the Totowa plant, contained more than double the required amount of active pharmaceutical ingredient, potentially putting patients at risk of serious and even fatal reactions. In August, the company voluntarily issued a recall of all other drug products produced at the site.

The latest round of problems apparently stemmed from the recent request from Actavis to restart production at the Totowa plant. In answer, the Justice Department issued a statement that Actavis has not demonstrated to the FDA that it can do this in compliance with the Good Manufacturing Practice requirements. The lawsuit seeks a permanent injunction barring the company, as well as two of its officers, from the manufacturing and distribution of generic drug products until they demonstrate compliance with the Good Manufacturing Practice requirements of the Federal Food, Drug and Cosmetic Act.

Additionally, the FDA warned Actavis against producing products containing ergotamine tartrate, which the agency considers an unapproved new drug. Despite the warning, the Department of Justice claims the company has continued to manufacture these unapproved products.

In response to the allegations, Actavis issued a statement saying that it "continues to work to address compliance issues," and is "confident that the actions it has taken to remedy the compliance and manufacturing issues at Actavis Totowa will exceed FDA's expectations." John LaRocca, Actavis' Chief Legal Officer, said, "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."

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