J&J Settles FDA Misbranding Case for $1.25 MillionMichelle Fay Cortez
Johnson & Johnson’s Advanced Sterilization Products unit and two of its executives agreed to pay $1.25 million to settle U.S. regulatory claims that the business sold misbranded products in 2012.
ASP manufactured and sold Sterrad Cyclesure 24 Biological Indicators, used to monitor and verify sterilization procedures, even though the company knew they had potentially faulty expiration dates, the Food and Drug Administration said today in a statement. A June 2012 inspection found the company hadn’t proven the biologic indicators would be effective for their entire 15 month shelf life. They were recalled a month later.
The settlement includes a $1.2 million payment by ASP, a $30,000 payment by unit President Bernard Zovighian and a $20,000 payment from Richard Alberti, vice president of quality and regulatory compliance. It resolves the FDA’s complaint for civil money penalties filed against the company in July 2013.
“Accurate expiration dates are critical to ensuring product integrity,” said Steve Silverman, director of the Office of Compliance in the FDA’s devices and radiological health center. “ASP’s actions violated the law and put patients at unnecessary risk for infection.”
The settlement resolves the complaint for civil penalties and isn’t an admission of liability or fault by ASP or its two executives, Diana Campau, an ASP spokeswoman, said in an e-mail. Customers can continue to use the Sterrad Cyclesure 24 Biological Indicator product as directed, she said.
The company fixed the problem with the expiration dates by reducing the shelf-life on their labels, the FDA said.