FDA and Advanced Sterilization Products Reach $1.25 Million Settlement

The settlement is reached after the company and its executives are shown to have distributed adulterated and misbranded devices, according to FDA.

FDA has reached a $1.25 million settlement of a civil money penalty action with Advanced Sterilization Products (ASP). Two executives from the company allege that it manufactured and distributed misbranded and adulterated sterilization monitoring products.

A division of Ethicon Inc., ASP will have to pay $1.2 million as part of the settlement, while ASP's President Bernard J. Zovighian will have to pay $30,000 and VP of Quality and Regulatory Compliance Richard J. Alberti will have to pay $20,000.

According to the FDA, a 2012 inspection at ASP showed the company had data suggesting that the "effectiveness of the biological indicators had not been established for the entire 15-month shelf life indicated in the product labeling." Shortly thereafter, the company recalled the product in question, Sterrad Cyclesure 24 Biological Indicators. In 2013, the FDA filed a complaint for civil money penalties against the company's executives.

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  • OHS Magazine Digital Edition - January 2019

    January 2019

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