The U.S. Food and Drug Administration (FDA) today announced that it has settled a civil penalty case against Johnson & Johnson company Advanced Sterilization Products (ASP). ASP has agreed to pay $1.25 million over misbranded products that it distributed.
Two ASP executives have also settled with the FDA over the matter. ASP President Bernard Zovighian has agreed to pay $30,000 and ASP Vice President of Quality and Regulatory Compliance Richard Alberti will pay $20,000.
The case involves allegations that ASP knowingly shipped its Sterrad Cyclesure 24 Biological Indicators with inaccurate expiration dates. The FDA in 2012 learned that ASP had determined in a study that it did not have sufficient evidence to support its stated 15-month shelf life for the product. A recall was issued shortly after the FDA's findings were released and ASP has since shortened its stated shelf life for the product.
“Accurate expiration dates are critical to ensuring product integrity,” said Steve Silverman, director of the Office of Compliance in the Center for Devices and Radiological Health at the FDA. “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.”
This settlement comes less than one month after a different Johnson & Johnson subsidiary settled a different lawsuit and agreed to pay $2.5 billion. That settlement involved DePuy Orthopaedics' knowledge that their hip replacements could release small metal particles into the bodies of patients.