Johnson & Johnson unit to pay $1.25 million to settle FDA misbranding case over sterilisation monitoring products
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By: Katie Bell
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Published: 12/05/2013
The FDA announced an agreement under which a unit of Johnson & Johnson's Ethicon division, Advanced Sterilization Products (ASP), will pay $1.25 million to settle claims that it manufactured and distributed adulterated and misbranded sterilisation monitoring products. The settlement calls for ASP to pay $1.2 million, with president Bernard J. Zovighian paying $30 000 and vice president of Quality and Regulatory Compliance Richard J. Alberti paying $20 000.
The agency noted that the civil money penalty action was taken in July after the regulator learned during an inspection last year that ASP knew that it did not have sufficient data to support the 15-month shelf life stated on the label of its Sterrad Cyclesure 24 Biological Indicators, but continued to ship the product with inaccurate expiration dates. The products are used to monitor and confirm the effectiveness of the sterilisation process in ASP's Sterrad sterilisers. The company recalled the affected products in July 2012. "Accurate expiration dates are critical to ensuring product integrity," said Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health, adding "ASP's actions violated the law and put patients at unnecessary risk for infection."
ASP said that the penalty "does not constitute an admission of liability or fault," adding that the Sterrad Cyclesure units currently on the market are safe to use. The FDA indicated that ASP has reduced the labelled shelf-life on the recalled products.
The agency noted that the civil money penalty action was taken in July after the regulator learned during an inspection last year that ASP knew that it did not have sufficient data to support the 15-month shelf life stated on the label of its Sterrad Cyclesure 24 Biological Indicators, but continued to ship the product with inaccurate expiration dates. The products are used to monitor and confirm the effectiveness of the sterilisation process in ASP's Sterrad sterilisers. The company recalled the affected products in July 2012. "Accurate expiration dates are critical to ensuring product integrity," said Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health, adding "ASP's actions violated the law and put patients at unnecessary risk for infection."
ASP said that the penalty "does not constitute an admission of liability or fault," adding that the Sterrad Cyclesure units currently on the market are safe to use. The FDA indicated that ASP has reduced the labelled shelf-life on the recalled products.