McNeil Consumer Healthcare Division of McNEIL-PPC, Inc., part of Johnson & Johnson, has formed an agreement with the US Attorney’s Office for the Eastern District of Pennsylvania and the US Department of Justice to resolve a previously disclosed government investigation relating to the manufacturing of certain over-the-counter products at its Fort Washington, Pennsylvania facility.

The investigation commenced after the company’s voluntary recalls of various products that occurred between 2008 and 2010. The voluntary recalls were not undertaken because of health or safety risks to consumers. Under the resolution, McNeil will enter a plea to a single misdemeanor violation of the Federal Food, Drug, and Cosmetic Act and accepts responsibility for the inadequate filing of required documents during the manufacturing process and will pay a settlement of $25 million.

“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, in a company statement. “McNeil has been implementing enhanced quality and oversight standards across its entire business to ensure we are best able to meet our commitment to consumers, patients and doctors who rely on our products.”

In 2011, the company agreed to a consent decree with the US Food and Drug Administration (FDA) regarding the operation of McNeil manufacturing facilities in Fort Washington and Lancaster, Pennsylvania and Las Piedras, Puerto Rico. A third party current good manufacturing practices (cGMP) expert has submitted written certification to the FDA for the aforementioned manufacturing facilities after determining that all three sites are in conformity with applicable laws and regulations.

Source: Johnson & Johnson