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PHILADELPHIA — (Mealey’s) The McNeil-PPC Inc. subsidiary of Johnson & Johnson on March 10 pleaded guilty to a federal misdemeanor criminal charge of making adulterated children’s over-the-counter medicines and agreed to pay a criminal fine and forfeiture totaling $25 million (United States of America v. McNeil-PPC, Inc., No. 15-82, E.D. Pa.).
McNeil-PPC pleaded guilty in the U.S. District Court for the Eastern District of Pennsylvania to failing to make infant’s and children’s liquid medicines in conformance with federal current Good Manufacturing Practices (cGMP) in violation of the Food, Drug and Cosmetic Act (FDCA).
According to a U.S. brief in support of the guilty plea, because McNeil-PPC remains under a 2011 consent decree of permanent injunction, the company will not be placed on probation (See 3/17/11, Page 10). “The proposed criminal resolution is sufficient to punish McNeil for its past failures and to deter McNeil from violating the FDCA in the future,” the government says.
“The permanent injunction will help to ensure that McNeil manufactures product in compliance with cGMP going forward,” it says.
Metal Found In Tylenol
The plea agreement also includes a non-prosecution clause, the government brief says. McNeil-PPC has waived its appeal rights.
According to a March 9 criminal information filed in the District Court, in 2009 McNeil received a consumer complaint about specks of foreign material in a bottle of Infant’s Tylenol. It said the foreign material was later identified as nickel and chromium.
The government says part of the machinery used to make children’s liquid medicines at the Fort Washington, Pa., plant is made from Waukesha II, a composite metal that is mostly nickel but also includes tin, iron, bismuth and chromium.
No Corrective Action Plan
The criminal information says that McNeil failed to initiate or complete a Corrective Action Preventative Plan (CAPA) when it learned about the contamination.
The information says there were numerous other instances in which McNeil found metal particles in bottles of Infant’s Tylenol made at its Fort Washington manufacturing plant but failed to initiate a CAPA. A 2010 inspection of the plant by the Food and Drug Administration found 30 batches of over-the-counter liquid drugs, including Infant’s Tylenol, Children’s Tylenol and Children’s Motrin, that didn’t conform to cGMPs.
During a 2011 inspection, the information says that McNeil confirmed that there were no CAPAs for foreign material found in the medicines.
McNeil: No Health, Safety Risks
In 2010, McNeil recalled all lots of infant’s and children’s over-the-counter drugs made at the Fort Washington plant.
In a March 10 news release, McNeil said the 2010 recalls “were not undertaken because of health or safety risks to consumers.”
McNeil closed the Fort Washington plan in 2011 for remediation. It has yet to reopen, according to the federal government.
In its statement, McNeil says that a third-party cGMP expert has submitted written certification to the FDA for the manufacturing plants in Fort Washington, Lancaster, Pa., and in Las Piedras, Puerto Rico, after determining that all three sites “are in conformity with applicable laws and regulations.”
The United States is represented by Louis D. Lappen, Mary E. Crawley and Mary Beth Leahy of the U.S. Attorney’s Office in Philadelphia and Benjamin C. Mizer, Michael S. Blume and Jeffrey I. Steger of the Justice Department in Washington, D.C.
McNeil-PPC is represented by Thomas M. Gallagher, Michael A. Schwartz and Abigail A. Hazlett of Pepper Hamilton in Philadelphia and Ethan M. Posner and Christopher M. Denig of Covington & Burling in Washington.
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