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.