FDA Reaches $1.25M Settlement With J&J Unit Over Faulty Sterilization Equipment
The Food and Drug Administration said Wednesday that it reached a $1.25 million settlement with a division of Johnson & Johnson over allegations that it knowingly shipped faulty sterilization equipment used by hospitals.
Under the civil penalty, Advanced Sterilization Products, a unit of J&J's Ethicon business, will pay $1.2 million to settle allegations that it made and sold "adulterated and misbranded" sterilization monitoring products, the FDA said. Two company executives will pay an additional $30,000 and $20,000, respectively.
The action settles allegations that the company shipped sterilization equipment with inaccurate expiration dates, despite knowledge that the shelf-life listed on the products was not supported by data. The company's Sterrad Cyclesure 24 Biological Indicators are used to confirm the sterilization process used to clean hospital instruments.
The FDA first learned that the company did not have evidence to support the entire 15-month shelf life printed on the label during a June 2012 inspection. The company recalled the devices the following month.
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.