Oxycodone is reportedly the first product to be manufactured at Actavis’s Little Falls, New Jersey facility following a recently completed FDA inspection.
In December 2008, Actavis has reached agreement on a consent decree of permanent injunction with the FDA regarding the company’s Actavis Totowa subsidiary. This decree only impacted operations at Actavis Totowa’s three facilities: two in Totowa, New Jersey and one in Little Falls, New Jersey.
Actavis agreed to not distribute any products from the Actavis Totowa facilities until it certified completion of certain enumerated requirements that demonstrate compliance with FDA’s current good manufacturing practice and has passed follow-up FDA inspections of the facilities.
Nasrat Hakim, vice president of quality compliance and technical services at Actavis, said: “Through an extensive process, Actavis re-qualified all equipment and utilities for production and packaging – and we re-qualified and revalidated all methods used to release products from our Totowa facilities. This is a very positive step and took incredible team work. The next step in the process will involve additional interaction with the FDA so that we can continue to introduce products as outlined in the consent decree.”