FDA Files Consent Decree against Johnson & Johnson

Last Thursday, FDA filed a consent decree of permanent injunction against McNeil, a subsidiary of Johnson & Johnson, for failing to comply with current good manufacturing practice requirements. The action prevents McNeil from manufacturing and distributing drugs from its Fort Washington, Pennsylvania, facility until FDA determines that its operations comply with the law.

From 2009 to 2010, FDA inspections at McNeil’s Las Piedras, Puerto Rico; Lancaster, Pennsylvania; and Fort Washington facilities found violations of the Federal Food, Drug, and Cosmetic Act. Under the decree, McNeil must adhere to a strict timetable to bring these facilities into compliance.

The decree also requires McNeil to destroy all drugs that have been recalled from the Fort Washington, Las Piedras, and Lancaster facilities since December 2009. McNeil must retain an independent expert who will inspect the facilities to determine whether the violations have been corrected, and ensure that adequate manufacturing processes are in place.

The consent decree names McNeil Consumer Healthcare Division’s vice-president of quality and the company’s vice-president of operations for over-the-counter products as defendants. If the defendants violate the decree, FDA may order McNeil to cease manufacturing or recall products. The agency also may levy fines of $15,000 for each day and an additional $15,000 for each violation of the law, to a maximum of $10 million annually. The decree was filed with the US District Court for the Eastern District of Pennsylvania in Philadelphia.

“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 FDA’s Center for Drug Evaluation and Research, in an agency press release.

Manufacturing deficiencies at McNeil’s facilities have resulted in several recalls, including an April 30, 2010, recall of lots of liquid products, including children’s Tylenol, Motrin, Zyrtec, and Benadryl products. In January 2010, FDA issued a Warning Letter to McNeil’s Consumer Healthcare Division regarding violations identified at McNeil’s Las Piedras facility.

See related Pharm Tech articles:
Consent Decree (Finally) for J&J (blog post)

J&J Recalls Yet More Medicines (Pharm Tech Europe)

J&J Plans to Improve Manufacturing Quality (blog post)