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Can You Trust Your Biological Indicators?

Advanced Sterilization Products Penalized $1.25M for Distributing Sterrad Sterilization Indicators with Inaccurate Expiration Dates

Published: December 5, 2013

Advanced Sterilization Products and 2 of its top executives have entered into a $1.25 million settlement over biological indicators that the U.S. Food and Drug Administration says were knowingly distributed with inaccurate expiration dates.

The Irvine, Calif.-based reprocessing technology manufacturer has agreed to pay the agency $1.2 million, company President Bernard J. Zovighian $30,000 and Vice President of Quality and Regulatory Compliance Richard J. Alberti $20,000.

The FDA discovered during a June 2012 inspection that the company had data that cast doubt on whether its Sterrad Cyclesure 24 biological indicators, used to monitor its Sterrad low-temperature sterilization device, were effective for the 15-month shelf life with which they'd been labeled.

"Accurate expiration dates are critical to ensuring product integrity," says the FDA's Steve Silverman in the agency's announcement of the settlement. "ASP's actions violated the law and put patients at unnecessary risk for infection."

The company voluntarily recalled the affected indicators in July 2012, and has since scaled back the product's stated shelf life.

In July of this year, the FDA sought civil monetary penalties for the "adulterated and misbranded" products.

The company said in a statement that the penalty "does not constitute an admission of liability or fault by Advanced Sterilization Products or the two named ASP executives." It added that ASP's Sterrad Cyclesure units currently on the market are safe to use.

David Bernard


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