McNeil Consumer Healthcare has reached an agreement with the U.S. Attorney’s Office for the Eastern District of Pennsylvania and the Department of Justice to resolve an investigation into the manufacture of some over-the-counter products at its Fort Washington facility.
The investigation followed the voluntary recall of several products by the company that occurred between 2008 and 2010. According to McNeil, the voluntary recalls were not performed due to health or safety risks to consumers.
Under the agreement, McNeil, which is part of Johnson & Johnson‘s healthcare products group, will enter a plea to a single misdemeanor violation of the Federal Food, Drug, and Cosmetic Act.
This means that the company will accept responsibility for the inadequate filing of documents required during the manufacturing process, and will pay a $25 million settlement.
”This plea agreement fully and finally resolves the federal government’s investigation, and closes a chapter on actions that led the company to review and significantly improve its procedures,” said Carol Goodrich, a spokesperson for McNeil Consumer Healthcare.
She added that McNeil has been implementing improved quality and oversight standards throughout its entire business. These will ensure that it is able to meet its ongoing commitment to the consumers, patients and doctors who rely on its products.