PHILADELPHIA -- (Mealey's) The McNeil-PPC Inc. division of Johnson & Johnson on March 10 entered into a consent decree of permanent injunction with the federal government for manufacturing violations at three plants that resulted in several over-the-counter products being recalled and one plant being shut down (United States of America v. McNeil-PPC, Inc., et al., No. 11-1745, E.D. Pa.).
In a March 10 complaint filed in the U.S. District Court for the Eastern District of Pennsylvania, the federal government alleged that McNeil and two employees violated the Food, Drug and Cosmetic Act by placing adulterated drugs into interstate commerce and causing drugs held for sale to become adulterated. The two employees are Veronica Cruz, McNeil's vice president of quality since February 2010, and Hakan Erdemir, vice president of operations for over-the-counter products since May.
The government says inspections of McNeil plants in Fort Washington and Lancaster, Pa., and in Las Piedras, Puerto Rico, found violations of current good manufacturing practices (CGMP).
Also on March 10, McNeil-PPC entered into a consent decree of permanent injunction, which requires it to schedule the destructions of all recalled products, to hire a CGMP expert to determine if violations at the three plants have been corrected and to hire a quality auditor to check compliance with regulations. The decree also contains a schedule for all three plants to be brought into compliance or face fines of $15,000 for each violation, $15,000 per day and up to $10 million a year.
The consent decree will remain in effect for five years.
In a March 10 press release, McNeil said that since July, it has implemented a comprehensive action plan to improve quality systems at all its U.S. manufacturing plants.
Manufacturing problems in April resulted in the recall of several liquid products such as Children's Tylenol, Motrin, Zyrtec and Benadryl. That month, McNeil closed down its Fort Washington plant for remediation.
The Lancaster and Las Piedras plants remain open.
It is not known if the consent decree resolves a grand jury subpoena McNeil and Johnson & Johnson told shareholders it received from the U.S. attorney for the Eastern District of Pennsylvania and a civil investigative demand it received for records relating to an investigation into possible violations of the False Claims Act.
[Editor's Note: Full coverage will be in the March 17 issue of Mealey's Emerging Drugs & Devices. In the meantime, the complaint and consent decree are available at www.mealeysonline.com or by calling the Customer Support Department at 1-800-833-9844. Complaint. Document #28-110317-006C. Consent decree of permanent injunction. Document #28-110317-007P. For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]
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