Actavis - Pharma manufacturing consent decrees

Start Date: 2008
Financial penalties: none
End Date: still pending

Actavis was cited for GMP violations in all of the products made at the three New Jersey facilities of its Totowa subsidiary. The FDA blocked all production at the plants. Actavis was required to retain a third-party expert to ensure GMP compliance, and it hired PAREXEL.

The drugmaker replaced the management team at its Little Falls plant for oral-dose manufacturing, where it makes Oxycodone products. The other plants involved were Riverview, also a site of oral-dose manufacturing, and Taft, a packaging facility.

Oxycodone production resumed in 2009.

Actavis - Pharma manufacturing consent decrees