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FDA issues consent decree for J&J's McNeil

Johnson & Johnson McNeil barred from manufacturing drugs at Fort Washington plant until FDA determines operations are in compliance with a consent decree

The US Food and Drug Administration (FDA) has filed a consent decree against Johnson & Johnson's McNeil unit barring the company from manufacturing and distributing drugs from its Fort Washington, Pennsylvania, facility until the FDA determines that its operations are in compliance.

The Fort Washington facility and two other McNeil facilities were found to be in violation of the good manufacturing practices required by the Federal Food, Drug, and Cosmetic Act during inspections in 2009 and 2010. The inspections followed a spate of high-profile recalls, including an April 30, 2010 recall of Children's Tylenol, Motrin, Zyrtec and Benadryl.

The company voluntarily closed the Fort Washington plant in April 2010 and said that it would not reopen the plant until remediation efforts were completed. Under the consent decree, the company will need the FDA's approval before the facility reopens.

The consent decree, which was filed with the US District Court for the Eastern District of Pennsylvania in Philadelphia, also requires McNeil to adhere to a strict timetable to bring its facilities in Las Piedras, Puerto Rico, and Lancaster, Pennsylvania, into compliance.

In addition, it requires McNeil to destroy all drugs under the company's control that have been recalled from the Fort Washington, Las Piedras, and Lancaster facilities since December 2009 and to hire an independent expert to inspect the facilities before the FDA reinspects them.

Violations of the decree could result in fines of $15,000 for each day and $15,000 for each violation, up to $10m a year.

Along with the company itself, the FDA's consent decree names McNeil Consumer Healthcare Division's vice president of Quality and the company's vice president of Operations for OTC Products as defendants.

The action was filed by the US Department of Justice's Office of Consumer Litigation and the US Attorney's Office for the Eastern District of Pennsylvania. It is subject to approval by the US District Court for the Eastern District of Pennsylvania.

"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.

McNeil said it believes that the terms of the consent decree "recognise the progress made in remediation efforts to date" and are in line with its own plans under a comprehensive action plan (CAP) for improving its US quality control that it submitted to the FDA in July 2010. "The consent decree allows McNeil to continue the work already initiated under the CAP, and identifies procedures that will help provide additional assurance of product quality to the FDA," according to the company.

11th March 2011

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