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FDA Reaches $1.25 Million Settlement Against J&J’s ASP Over Medical Device Shelf Life


Posted in Regulatory and Compliance by MDDI Staff on January 16, 2014

The company did not have sufficient data to support the shelf life stated on the label of its Sterrad Cyclesure 24 Biological Indicators. 


By Jim Dickinson

                                   

FDA has reached a $1.25 million civil money penalty settlement against Johnson & Johnson’s Advanced Sterilization Products (ASP) and two executives, alleging that they manufactured and distributed adulterated and misbranded sterilization monitoring products.

Avoid running afoul of FDA by attending the FDA and Global Regulations in Practice conference track at MD&M West in Anaheim, CA, February 10–13, 2014.

The settlement requires ASP to pay $1.2 million, president Bernard J. Zovighian to pay $30,000, and quality and regulatory compliance vice president Richard J. Alberti to pay $20,000, according to an agency news release.

The settlement was reached after FDA learned during a 2012 inspection that the company knew it did not have sufficient data to support the shelf life stated on the label of its Sterrad Cyclesure 24 Biological Indicators. The devices 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,” CDRH Office of Compliance director Steve Silverman said in a statement. “ASP’s actions violated the law and put patients at unnecessary risk for infection. The FDA is committed to enforcing the law and protecting the public from the potential harms associated with inaccurate product information.”

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

Avoid running afoul of FDA by attending the FDA and Global Regulations in Practice conference track aMD&M West in Anaheim, CA, February 10–13, 2014.

—Jim Dickinson is MD+DI's contributing editor.

[image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

 


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