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FDA, DOJ Take Action Against Johnson & Johnson-McNeil

Cristina Arias/Getty Images(WASHINGTON) -- The U.S. Food and Drug Administration and the Department of Justice announced Thursday afternoon that McNeil Consumer Healthcare (a unit of Johnson & Johnson) and two of its executives have been accused of violations of federal law for failing to comply with good manufacturing practices in connection with a series of product recalls and poor inspection reports at its manufacturing facilities.
Without admitting or denying the allegations, McNeil has entered into a consent decree with the government that places three of the company’s plants under supervision of the FDA. The decree also prevents them from reopening their Fort Washington, Pa. plant until it has been found by the FDA to be in compliance with the law.
McNeil can continue operating two of its other plants, one in Puerto Rico and the other in Lancaster, Pa., but the company must submit to independent inspections and adhere to a strict timetable to bring those facilities into compliance.

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