(U.S. FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) announced 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 Practices’ (cGMP) requirements as required by federal law. The action prevents McNeil, a subsidiary of Johnson & Johnson, from manufacturing and distributing drugs from its Fort Washington, Pennsylvania, facility until the FDA determines that its operations are compliant with the law.

McNeil Consumer Healthcare Division’s vice president of quality and the company’s vice president of operations for over-the-counter (OTC) products also were named defendants in the consent decree, filed with the U.S. District Court for the Eastern District of Pennsylvania in Philadelphia on March 10.

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

“This FDA drug-safety enforcement action is aimed at protecting the public health,” says Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs.

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