The U.S. Food and Drug Administration and the U.S. Department of Justice filed consent decree of permanent injunction against Johnson & Johnson subsidiary McNeil-PPC, banning the company from manufacturing and distributing drugs from its Fort Washington, Pa., facility until the FDA determines that its operations are compliant with the law.
The decree also requires McNeil to adhere to a strict timetable to bring its facilities in Las Piedras and Lancaster, Pa., into compliance, but does not require them to shutter.
The company was charged with manufacturing and distributing over-the-counter drugs in violation of federal law. The consent decree filed Thursday at the U.S. District Court for the Eastern District of Pennsylvania also names McNeil Consumer Healthcare Division’s vice president of quality and the company’s vice president of operations for OTC Products as defendants.
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.
“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 children’s Tylenol, Motrin, Zyrtec, and Benadryl products. In January 2010, the FDA issued a warning letter to McNeil’s Consumer Healthcare Division regarding violations identified at McNeil’s Las Piedras facility.
The decree requires McNeil to destroy all drugs under its 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.
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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