Executive Summary

Actavis Totowa said FDA gave it approval to resume production of painkiller oxycodone 15 mg and 30 mg tablets at its Little Falls, N.J., facility following an agency inspection. The reopening will help ease a shortage of oxycodone that followed various FDA enforcement actions, including one that led Actavis last August to recall oxycodone and 65 other products made at its Little Falls plant, which shut down after FDA found numerous GMP violations. A Dec. 29 FDA consent decree set conditions for resuming production at Little Falls and two Totowa, N.J., facilities. "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," said Nasrat Hakim, vice president of quality compliance and technical services for Actavis