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

Reuters

Dec 4 (Reuters) - Advanced Sterilization Products, adivision of Johnson & Johnson's Ethicon unit, agreed toa $1.25 million settlement with the U.S. Food and DrugAdministration over allegations that it sold adulterated andmisbranded 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 andRichard Alberti, vice president of quality and regulatorycompliance, will pay $20,000.

The agency said the company knew that it did not havesufficient data to support the labeled shelf life of a productused to monitor and confirm the effectiveness of the process incertain sterilizers.

J&J, grappling with a series of quality issues, over thepast three years has recalled dozens of over-the-counterproducts made at its plants in Pennsylvania and Puerto Rico thatwere shown to have foreign particles or incorrect concentrationsof active ingredients.

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

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