FORT WASHINGTON, Pa. — McNeil last week finalized the terms of a consent decree of permanent injunction with the Food and Drug Administration for manufacturing facilities operated by the McNeil Consumer Healthcare Division in Las Piedras, Puerto Rico; Fort Washington, Pa.; and Lancaster, Pa.
The consent decree is subject to approval by the U.S. District Court for the Eastern District of Pennsylvania.
Under the terms of the consent decree, the company will continue to operate the manufacturing facilities in Las Piedras and Lancaster. The company will work with an independent expert who will inspect these sites and issue recommendations. Based on these findings, the company will develop remediation plans to address observations identified by the independent expert. These plans will be submitted to the FDA and are subject to the agency’s approval.
In addition, the company and the FDA have agreed on a plan to have the independent expert review certain manufacturing records at the two sites while remediation is ongoing to ensure that products released from the sites continue to meet quality standards.
The company expects that the consent decree will govern its operation of the facilities for a period of at least five years following the completion of the remediation plan.
In April 2010, McNeil voluntarily closed its manufacturing facility in Fort Washington, Pa., and announced that it would not re-open the plant until it completed its planned remediation efforts at that facility. According to the terms of the consent decree, the company will not re-open the Fort Washington facility unless it first completes remediation efforts at the facility, receives a certification of compliance from an independent expert and then receives approval from the FDA.
“This is a strong but necessary step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity,” stated Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
The decree, filed by the U.S. Department of Justice’s Office of Consumer Litigation and the U.S. Attorney’s Office for the Eastern District of Pennsylvania, requires McNeil to destroy all drugs under its control that have been recalled from the Fort Washington, Las Piedras and Lancaster facilities since December 2009.
The decree becomes effective when it has been entered by the court, the FDA stated.