US FDA, Justice Department take action against Johnson & Johnson McNeil unit

The US Food and Drug Administration says that a consent decree of permanent injunction has been filed against McNeil-PPC - unit of health care giant Johnson & Johnson (NYSE: JNJ) - and two of its officers for failing to comply with current good manufacturing practice requirements as required by federal law relating to numerous recalls of the firm’s over-the-counter medicines that last year cost J&J around $900 million in lost sales.

The action prevents McNeil 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 VP of operations for OTC Products also were named defendants in the consent decree, filed with the US District Court for the Eastern District of Pennsylvania in Philadelphia on March 10, 2011. 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.