J&J sterilization unit to pay $1.25 mln for FDA violations

Wed Dec 4, 2013 5:39pm EST

Dec 4 (Reuters) - Advanced Sterilization Products, a division of Johnson & Johnson's Ethicon unit, agreed to a $1.25 million settlement with the U.S. Food and Drug Administration over allegations that it sold adulterated and misbranded monitoring products, the agency said on Wednesday.

The FDA said Advanced Sterilization will pay $1.2 million, while company President Bernard Zovighian will pay $30,000 and Richard Alberti, vice president of quality and regulatory compliance, will pay $20,000.

The agency said the company knew that it did not have sufficient data to support the labeled shelf life of a product used to monitor and confirm the effectiveness of the process in certain sterilizers.

J&J, grappling with a series of quality issues, over the past three years has recalled dozens of over-the-counter products made at its plants in Pennsylvania and Puerto Rico that were shown to have foreign particles or incorrect concentrations of active ingredients.

The company agreed last month to pay an estimated $2.5 billion to settle thousands of lawsuits from individuals allegedly injured by the company's artificial metal hip implants.