FDA To Take Over Three Tylenol Manufacturing Plants As Part Of Consent Decree
On March 10, 2011, the FDA in cooperation with the Department of Justice announced that a consent decree had been filed against McNeil PPC (“McNeil”) and two of its executives for failing to comply with current good manufacturing practice (“cGMP”) regulations. In accordance with the consent decree, McNeil, a division of Johnson & Johnson, has agreed to place three of its Tylenol manufacturing plants, in Puerto Rico, Lancaster, Pa. and Fort Washington, Pa., under FDA supervision. A copy of FDAs press release can be read here.
The consent decree comes after numerous FDA inspections of the three facilities between 2009 and 2010 revealed violations of the Food, Drug, and Cosmetic Act (“FDCA”) and cGMP regulations. cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. If a company is not complying with cGMP regulations, any drug it makes is considered “adulterated” under the FDCA. More information regarding cGMPs is available at FDAs website. These cGMP violations resulted in McNeil issuing extensive product recalls for the over-the-counter drugs its plants produced, including Tylenol, Motrin, and Benadryl in May 2010.
The consent decree requires McNeil to adhere to a strict timetable for bringing its facilities into compliance. Under the terms of the consent decree filed by the Department of Justice in the Eastern District of Pennsylvania, McNeil is required to destroy all drugs under its control that have been recalled from the three facilities since December 2009. Additionally, McNeil must retain independent experts to inspect the three facilities to determine whether the violations have been corrected and to ensure that adequate manufacturing processes are in place. Upon expert certification, the FDA will then determine if the facilities are in compliance.
If McNeil violates the decree, the FDA may order McNeil to cease manufacturing, recall products, and take other corrective actions including fines of $15,000 per day per violation of law up to $10 million annually. If you have questions pertaining to the FDCA or cGMP regulations or how to ensure that your business maintains regulatory compliance at both the state and federal levels, contact Fuerst Ittleman PL at email@example.com.