Taking action in the wake of massive product recalls, the Food and Drug Administration has initiated the filing of a consent decree of permanent injunction against McNeil-PPC and two of its officers for failing to comply with federal good manufacturing practice requirements.


McNeil-PPC, McNeil Consumer Healthcare, Food and Drug Administration, FDA, Johnson & Johnson, consent decree, over-the-counter medicines, product recalls, good manufacturing practice, OTC products, Tylenol, Motrin, Zyrtec, Benadryl, Las Piedras, Fort Washington, Lancaster, U.S. District Court for the Eastern District of Pennsylvania, Department of Justicedrug companies






































































































































































































































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FDA initiates action against McNeil-PPC

March 11th, 2011

WASHINGTON – Taking action in the wake of massive product recalls, the Food and Drug Administration has initiated the filing of a consent decree of permanent injunction against McNeil-PPC and two of its officers for failing to comply with federal good manufacturing practice requirements.

The FDA said Thursday that the action prevents McNeil, a Johnson & Johnson subsidiary, from manufacturing and distributing drugs from its Fort Washington, Pa., facility until the agency determines that its operations are compliant with the law.

McNeil announced Thursday that the company has finalized the terms of the consent decree with the FDA for manufacturing facilities operated by its McNeil Consumer Healthcare Division in Las Piedras, Puerto Rico, and in Fort Washington and Lancaster, Pa. The company noted that the decree is subject to approval by the U.S. District Court for the Eastern District of Pennsylvania.

Under the terms of the decree, McNeil said, the company will continue to operate the manufacturing facilities in Las Piedras and Lancaster and will work with an independent expert who will inspect the sites and issue recommendations. Based on the findings, McNeil will then develop remediation plans to address observations identified by the expert, and those plans will be submitted to the FDA for approval.

In addition, McNeil said it has agreed with the FDA 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. McNeil reported that it expects the decree to govern the company's operation of the facilities for at least five years after the remediation plan is completed.

McNeil noted that last April it voluntarily closed its plant in Fort Washington and said it wouldn't reopen the facility until it finished its planned remediation efforts there. According to the decree, the company won't the Fort Washington plant unless it first has completed remediation efforts, receives a certification of compliance from an independent expert and then receives approval from the FDA.

Also on Thursday, the FDA announced that McNeil Consumer Healthcare's vice president of quality and its vice president of operations for OTC products were named as defendants in the consent decree.

Commenting on the agency's measures, FDA associate commissioner for regulatory affairs Dara Corrigan stated, "This FDA drug safety enforcement action is aimed at protecting the public health."

The FDA reported that its inspections at McNeil's Fort Washington, Las Piedras and Lancaster plants from 2009 to 2010 found violations of the Federal Food, Drug and Cosmetic Act, which requires drug companies to follow current good manufacturing practice requirements.

"This is a strong but necessary step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity," commented Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research.

The FDA noted that manufacturing deficiencies at McNeil's facilities have resulted in several extensive recalls of over-the-counter medicines, including an April 30, 2010, recall of lots of several liquid products such as children’s Tylenol, Motrin, Zyrtec and Benadryl products. In January 2010, the FDA issued a warning letter to McNeil Consumer Healthcare regarding violations identified at the Las Piedras facility.

The decree, filed by the 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, according to the FDA.

If the defendants violate the decree, the FDA may order McNeil to cease manufacturing, recall products, and take other corrective action, including levying fines, the agency said. The decree becomes effective when it has been entered by the court.

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