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.

  • 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.

  • Analyze Incident Data

    Collect relevant incident data, analyze trends, and generate accurate regulatory reports, including OSHA 300, 300A, and 301 logs, through IndustrySafe’s extensive incident reporting and investigation module.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common training questions.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Industry Safe
comments powered by Disqus

OH&S Digital Edition

  • OHS Magazine Digital Edition - March 2019

    March 2019

    Featuring:

    • HEARING PROTECTION
      Not Your Grandpa's Ear Muffs 
    • FALL PROTECTION
      Far Too Many Fatal Falls
    • DRUG TESTING
      Marijuana in the Workplace
    • FALL PREVENTION
      Ladder Safety Tips
    View This Issue