The Food and Drug Administration (FDA) has reached a $1.25 million settlement against Advanced Sterilization Products (ASP), a division of Ethicon Inc., a Johnson & Johnson company, and two of ASP’s executives over the manufacturing and distributing of adulterated and misbranded sterilization monitoring products. The civil money action against ASP requires the company 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.
The action resolves allegations that ASP knew it did not have sufficient data to support the shelf life printed 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 and sterilization process in Sterrad sterilizers.
Inaccurate expiration dates jeopardizes a product’s integrity. By knowingly shipping compromised products, it violated the law and put patients at unnecessary risk for infection, said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “The FDA is committed to enforcing the law and protecting the public from the potential harms associated with inaccurate product information.”
The FDA learned during an inspection in June 2012 that ASP had not established the effectiveness of the biological indicators for the entire 15-month shelf life indicated on the product’s labeling. ASP issued voluntary recalls of the affected products in July 2012. A year later, the FDA filed a complaint for civil money penalties against ASP and the company’s executives.
ASP has since addressed the shelf life issues relating to the recalled products by reducing the shelf life.