CGMP Violation

May 24, 2017

New York announced that 42 states and the District of Columbia have reached a $33 million settlement with Johnson & Johnson and Johnson & Johnson Consumer Inc., resolving allegations that the company’s subsidiary, McNeil-PPC, Inc., employed deceptive practices to market and promote numerous popular over-the-counter (“OTC”) drugs. In addition to reforming these practices, the corporation has agreed to pay New York State a total of $1.3 million. Between 2009 and 2011, McNeil-PPC, Inc.—then a wholly-owned subsidiary of Johnson & Johnson—manufactured and distributed OTC drugs that purported to comply with federally mandated current Good Manufacturing Practices (“cGMP”). However, an investigation conducted by the FDA and Attorneys General across the country revealed that a number of McNeil manufacturing facilities and the medications they produced did not meet the national cGMP standards. NY, NJ, TX, FL

March 10, 2015

Johnson & Johnson subsidiary McNeil-PPC Inc. pleaded guilty to selling adulterated infants’ and children’s over-the-counter liquid medicines, including Infants’ and Children’s Tylenol Motrin.  As part of the criminal resolution, McNeil agreed to pay a criminal fine of $20 million and forfeit $5 million.  DOJ

February 3, 2015

Medical device maker Atrium Medical Corporation, Maquet Holding B.V. & Co. KG, Maquet Cardiovascular LLC, and Maquet Cardiopulmonary AG were permanently enjoined from distributing adulterated and misbranded medical devices. According to the government, Atrium — which manufactures medical devices for cardiovascular-related uses, including chest drains, surgical meshes, vascular grafts and stent systems — was not complying with the FDA’s current good manufacturing practice requirements for medical devices which are designed to ensure the devices are safe and effective and otherwise in compliance with the federal Food, Drug and Cosmetic Act. DOJ

January 16, 2015

A federal court in California issued an injunction shutting down Health One Pharmaceuticals Inc., a manufacturer of dietary supplements and unapproved new drugs. The firm and its president, Richard S. Yeh, agreed to shut down and resolve the lawsuit as part of a consent decree. The government alleged, among other things, the defendants failed to meet current good manufacturing practices for dietary supplements by failing to conduct appropriate testing and misbranding the supplements because their labels did not include all the information required by federal law. DOJ