PHILADELPHIA – McNeil-PPC Inc., a subsidiary of Johnson & Johnson, has pleaded guilty to violating the federal Food, Drug and Cosmetic Act (FDCA) for manufacturing adulterated liquid medications intended for infants and children.
The company, charged with delivering drugs into interstate commerce that were deemed adulterated, agreed to pay a criminal fine of $20 million and forfeit $5 million. The guilty plea was announced by First Assistant U.S. Attorney Louis D. Lappen, Acting Assistant Attorney General Benjamin C. Mizer, and Director George M. Karavetsos.
According to court documents, McNeil’s Fort Washington facility produced OTC liquid drugs that contained nickel/chromium-rich inclusions, not intended ingredients. The company failed to initiate or complete a Corrective Action Preventive Action (CAPA) plan in response to consumer complaints and FDA inspections.
During a 2010 inspection, the FDA requested information on non-conformances related to particles and foreign material found in OTC drugs, revealing 30 batches of adulterated medications. McNeil also recalled all lots of certain unexpired Infants’ and Children’s OTC drugs distributed worldwide.
McNeil remains under a permanent injunction requiring remedial measures before reopening its manufacturing facility. Lappen emphasized that drug companies must adhere to rigorous quality standards, noting that failure to do so subjects them to penalties and prosecution.
The McNeil case underscores the importance of good manufacturing practices in pharmaceuticals, ensuring public safety.
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Key Facts
- State: Pennsylvania
- Agency: DOJ USAO
- Category: Fraud & Financial Crimes|Public Corruption|Organized Crime
- Source: Official Source ↗
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