FDA Stops Production of Tylenol at Three Plants

McNeil Consumer Healthcare division's vice president of Quality and the company's vice president of Operations for OTC Products are named in the consent degree.

The U.S. Food and Drug Administration announced on March 11 that a consent decree of permanent injunction has been filed against McNeil-PPC and two of its officers for failing to comply with current good manufacturing practice requirements as required by federal law.

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

The FDA also named McNeil Consumer Healthcare Division's vice president of Quality and the company's vice president of Operations for OTC Products.

The decree requires McNeil to destroy all drugs under McNeil's control that have been recalled from the Fort Washington, Las Piedras, and Lancaster facilities since December 2009. McNeil also must retain an independent expert to inspect the Fort Washington, Las Piedras, and Lancaster facilities to determine whether the violations have been corrected, and to ensure that adequate manufacturing processes are in place. After expert certification, the FDA will determine if the facilities are in compliance.

The decree also requires McNeil to adhere to a strict timetable to bring its facilities in Las Piedras, Puerto Rico, and Lancaster, Pa., into compliance.

FDA inspections at McNeil's Fort Washington, Las Piedras, and Lancaster facilities from 2009 to 2010 found violations of the Federal Food, Drug, and Cosmetic Act. The Act 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, said Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research.

Manufacturing deficiencies at McNeil's facilities have resulted in several extensive recalls, including an April 30, 2010, recall of lots of several liquid products such as childrens Tylenol, Motrin, Zyrtec, and Benadryl products. In January 2010, the FDA issued a Warning Letter to McNeils Consumer Healthcare Division regarding violations identified at McNeils Las Piedras facility.

If the defendants violate the decree, the FDA may order McNeil to cease manufacturing, recall products, and take other corrective action, including levying fines of $15,000 for each day and an additional $15,000 for each violation of the law, up to $10 million annually.

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