Actavis Totowa stops production at out-of-code US plants
The Consent Decree of Permanent Injunction, which was agreed on December 31, brings a halt to production at three of Actavis Totowa’s New Jersey plants: its two oral-dose manufacturing sites in Little Falls and Riverview; and its packaging facility in Taft.
The agreement also addresses the US Department of Justice’s (DoJ’s) injunction preventing Actavis executives Sigurdur Olafsson and Douglas Boothe from manufacturing and distributing generic pharmaceutical products.
An Actavis spokesperson told in-PharmaTechnologist that: “We have a new management team in place at Little Falls and we have invested significantly to reinforce systems and procedures intended to ensure robust, sustainable compliance.”
She went on to explain that the firm has “retained the well regarded firm Parexel to assess the three facilities and products made there,” adding that once “[Parexel] certifies a facility as GMP compliant, we will provide that certification to the FDA. We will then request an inspection.”
The spokesperson refuted the idea that the firm had been damaged by the saga and argued that: “Actavis Totowa is one subsidiary of the larger group, which has 11,000 employees in 40 countries. We are working to remedy and address the Totowa issues, and we will move forward.”
Actavis’ problems began in April last year when the US Food and Drug Administration (FDA) deemed that operations at Little Falls were not up to code. The firm was forced to recall batches of the heart drug Digitek (digoxin).made at the plant after tests revealed that it contained twice the approved level of active ingredient.
By August Actavis was forced to recall all products made at the plant including antidepressants, diet medications, painkillers and drugs for hypertension after an FDA investigation revealed that good manufacturing practices (GMP), including adequate quality controls, were not being followed.
Last November the DoJ filed for the injunction after Actavis’ requested that manufacture be allowed to restart. The DoJ responded that the firm had still not demonstrated that it was compliant with appropriate GMP standards.
