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 practice requirements established by federal law. McNeil, a subsidiary of Johnson & Johnson, will not be allowed to manufacture or distribute drugs from its Fort Washington, Penn., facility until the Food and Drug Administration (FDA) deems its operations comply with the law. Millions of over-the-counter medicines made at the facility have been recalled over the past year because of problems that were traced back to substandard quality control measures at the plant.
McNeil’s Consumer Healthcare Division Vice President of Quality and the Vice President of Operations for OTC Products were also named among the defendants in the consent decree, which was filed with the U.S. District Court for the Eastern District of Pennsylvania in Philadelphia. The decree also requires the company to adhere to a strict timetable to bring its facilities in Las Piedras, Puerto Rico and Lancaster, Penn., up to compliance.
“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.
If McNeil violates the decree, the FDA may order the company to cease manufacturing, issue another round of recalls, and take other corrective measures 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.