Thursday, December 5, 2013

Industry News: ASP to Pay $1.2 M to FDA for Unsupported Shelflife of Biological Indicators

The FDA issued a News Release on 12/4/13 saying that it had reached a$1.25 million settlement with Advanced Sterilization Products and company executives for distributing adulterated and misbranded devices.

 ... The settlement requires ASP to pay $1.2 million, company President Bernard J. Zovighian to pay $30,000, and company Vice President of Quality and Regulatory Compliance Richard J. Alberti to pay $20,000.

This action was taken after the FDA learned that the company knew that it did not have sufficient data to support the shelf life stated on the label of its Sterrad Cyclesure 24 Biological Indicators, but continued to ship the product to customers with inaccurate expiration dates. Sterrad Cyclesure 24 Biological Indicators are used to monitor and confirm the effectiveness of the sterilization process in ASP’s Sterrad sterilizers.

“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. “ASP’s actions violated the law and put patients at unnecessary risk for infection. ...”

During an inspection in June 2012, FDA learned that ASP had study data indicating that the effectiveness of the biological indicators had not been established for the entire 15-month shelf life indicated in the product labeling. ASP issued voluntary recalls of affected product in July 2012. ...

ASP has addressed the shelf-life issues relating to the recalled product by reducing the labeled shelf-life. ...

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