McNeil was charged by the US Attorney’s Office in the Eastern District of Pennsylvania with introducing interstate commerce drugs that were deemed adulterated, which is a misdemeanor. The company will pay a criminal fine of $20m (€18.7m) and forfeit $5m (€4.7m).
“McNeil’s failure to comply with current good manufacturing practices is seriously troubling,” said Acting Assistant Attorney General Benjamin Mizer of the Justice Department’s Civil Division. “The Department of Justice will continue to be aggressive in pursuing and punishing companies such as McNeil that disregard a process designed to assure quality medicines, especially OTC drugs for infants and children.”
According to court documents, the OTC liquid drugs manufactured by McNeil at its Fort Washington, Pennsylvania facility were bottled on four lines of machinery dedicated to liquid formulations.
In May 2009, McNeil received a complaint from a consumer regarding the presence of “black specks in the liquid on the bottom of the bottle” of Infants’ Tylenol. The foreign material included nickel/chromium-rich inclusions, which were not intended ingredients, but upon receiving the complaint, McNeil did not initiate or complete a Corrective Action Preventive Action (CAPA) plan in conformance with current Good Manufacturing Practices (cGMP).
McNeil also allegedly found metal particles in bottles of Infants’ Tylenol at the same facility, but failed to initiate or complete a CAPA.
During a 2010 inspection of the facility, the US FDA asked McNeil for a list with all non-conformances for particles and the associated OTC drug batches that had occurred since an FDA inspection in 2009, and McNeil provided a list of 30 batches of OTC liquid drugs, including Infants’ Tylenol, Children’s Tylenol, and Children’s Motrin.
During the same inspection, the FDA asked McNeil for the CAPA plan covering the particles and foreign material found in the Infants’ and Children’s OTC drugs, and a McNeil employee confirmed that the company did not have such a plan.
Later in 2010, a division of McNeil, in consultation with the FDA, recalled all lots of certain unexpired Infants’ and Children’s OTC drugs manufactured at the Fort Washington facility and distributed in the US and other countries. J&J halted production at the site in May 2010.
McNeil remains under a 2011 permanent injunction entered by the US District Court in the Eastern District of Pennsylvania, requiring it to, among other things, make remedial measures before reopening the facility. That same year the company also agreed to a Consent Decree with the US FDA regarding the operation of McNeil manufacturing facilities in Fort Washington and Lancaster, PA and Las Piedras, Puerto Rico.
The company said in a statement on Tuesday that a third party cGMP expert has submitted written certification to the FDA for the aforementioned manufacturing facilities after determining that all three sites are in conformity with applicable laws and regulations.
Carol Goodrich, a spokesperson for McNeil Consumer Healthcare, said in a statement: "McNeil has been implementing enhanced quality and oversight standards across its entire business to ensure we are best able to meet our commitment to consumers, patients and doctors who rely on our products."