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.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Comply with OSHA’s Electronic Recordkeeping Requirements

    Collect relevant incident data and generate accurate OSHA 300, 300A, and 301 regulatory reports, including 300A CSV files for easy electronic submission to OSHA.

  • Complete Online Safety Training Courses

    Deliver state-of-the art, online safety training courses to your organization with IndustrySafe Training Management Software. Generate reports to track training compliance and automatically notify learners of upcoming or overdue classes.

  • Easy to Use Safety Inspection App

    Conduct inspections on the go with IndustrySafe’s mobile app. Complete safety audits at job sites and remote locations—with or without web access.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Industry Safe
comments powered by Disqus