Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery and some of its top brass will pay $1.25 million to settle claims that its Advanced Sterilization Products division mis-labeled its products with expiration dates that were not supported by data.
The total charge is comprised of a $1.2 million fine for ASP, a $30,000 fine for company president Bernard Zovighian and a $20,000 fine for quality & regulatory compliance president Richard Alberti, according to an FDA notice.
"Accurate expiration dates are critical to ensuring product integrity," FDA Center for Devices & Radiological Health Office of Compliance director Steve Silverman said in prepared remarks. "ASP’s actions violated the law and put patients at unnecessary risk for infection."
The labeling snafu was discovered during a June 2012 inspection. FDA regulators reported that ASP knew that it didn’t have the data to support a 15-month shelf life for its Sterrad Cyclesure 24 Biological Indicators, part of its line of sterilization monitoring products. ASP recalled the products and revised expiration dates down to 6 months following the report.