McNeil Consumer Healthcare Division’s Vice President of Quality and the company’s Vice President of Operations for 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, 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.
Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs said, "This FDA drug safety enforcement action is aimed at protecting the public health."
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.
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.
READ MORE drug/medical LEGAL NEWS
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.