Johnson & Johnson Firm To Pay $1.25 Mln To Settle Civil Money Penalty Action

(RTTNews) - Advanced Sterilization Products and two of its executives have been ordered to pay $1.25 million by FDA to settle a civil money penalty action over allegations that the company distributed adulterated and misbranded devices.

Accordingly, Advanced Sterilization Products is required to pay $1.2 million, while the company President Bernard Zovighian and Vice President of Quality and Regulatory Compliance Richard Alberti are required to pay $30,000 and $20,000, respectively.

Advanced Sterilization Products is a division of Ethicon Inc., a Johnson & Johnson (JNJ) company.

A complaint for civil money penalties against Advanced Sterilization Products and its executives was filed by the FDA in July 2013, after it was learnt during an inspection last year that the company was shipping its Sterrad Cyclesure 24 Biological Indicators to customers with inaccurate expiration dates despite not having sufficient data to support the shelf life stated on the label. A voluntary recall of the affected products was issued by the company last July.

Sterrad Cyclesure 24 Biological Indicators are used to monitor and confirm the effectiveness of the sterilization process in ASP's Sterrad sterilizers.