The Food and Drug Administration (FDA) has reached a $1.25 million settlement of a civil money penalty action against Advanced Sterilization Products (ASP), a division of Ethicon Inc., a Johnson & Johnson company, and two of ASP’s executives alleging that ASP manufactured and distributed adulterated and misbranded sterilization monitoring products.
The settlement requires ASP to pay $1.2 million, company president Bernard J. Zovighian to pay $30,000, and company vice president of quality and regulatory compliance Richard J. Alberti to pay $20,000.
This action was taken after the FDA learned that the company knew that it did not have sufficient data to support the shelf life stated on the label of its Sterrad Cyclesure 24 Biological Indicators, but continued to ship the product to customers with inaccurate expiration dates. Sterrad Cyclesure 24 Biological Indicators are used to monitor and confirm the effectiveness of the sterilization process in ASP’s Sterrad sterilizers.
“Accurate expiration dates are critical to ensuring product integrity,” says Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “ASP’s actions violated the law and put patients at unnecessary risk for infection. The FDA is committed to enforcing the law and protecting the public from the potential harms associated with inaccurate product information.”
During an inspection in June 2012, FDA learned that ASP had study data indicating that the effectiveness of the biological indicators had not been established for the entire 15-month shelf life indicated in the product labeling. ASP issued voluntary recalls of affected product in July 2012.
In July 2013, the FDA filed a complaint for civil money penalties against ASP and the company’s executives alleging that ASP had manufactured and distributed adulterated and misbranded devices. This settlement resolves the civil money penalty action.
ASP has addressed the shelf-life issues relating to the recalled product by reducing the labeled shelf-life. For more information, visit the FDA Safety Communication: UPDATE on Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicators Revised Expiration Dates.