Decontamination technologies maker Steris Corp. (NYSE:STE) struggles with the U.S. Food and Drug Administration continue, as the agency cited the company for making improper marketing claims about several steam-sterilization devices.
The FDA sent Steris a warning letter, dated Feb. 9, alleging that the Mentor, Ohio-based company mis-branded its devices by making claims about the devices’ capabilities that were not cleared by the FDA as part of Steris’ 510(k) applications for market clearance.
“Our recent review of your labeling, brochures and other materials used to promote your products and your website finds that you are making claims that were determined to be unacceptable during the review of your 510(k) submissions,” the FDA said in the warning letter.
FDA warning letters are considered by the FDA to be informal and advisory and don’t necessarily indicate that the FDA intends to take any punitive action against recipients. The FDA asked Steris to respond within 15 days with a list of the steps it plans to take to correct the violations.
“Steris is reviewing this matter and expects to respond within that time period,” the company said in a Securities & Exchange Commission filing. “We do not believe that the impact of this event will have a material adverse effect on our financial results.”
Specifically, several of the violations cited by the FDA relate to chemical indicators, which are used, for example, to indicate whether the presence of chemicals is detected on a medical instrument. In one instance, the FDA cited Steris for claiming that chemical indicators are “designed to measure sterility success.”
The FDA objected to the claim because it said the indicators do not measure “success,” rather they measure “only that a particular sterilizer cycle met the designated physical parameters for that cycle,” according to the warning letter.
Steris would need to submit a new 510(k) application to be cleared to make the claims it did in the marketing materials, according to the warning letter.
Several events over the past year or so have likely strained the relationship between Steris and the FDA — behind closed doors, at least.
Most significantly, Steris is still operating in the shadow of events brought on by a December 2009 federal safety alert about its flagship System 1 sterilization device. The FDA warned that the system could cause harm to patients. The company has been working to transition customers to its new System 1E product, but recently downgraded its full-year sales projection due to apparent delays in FDA clearance of an accessory part.
Additionally, the company received a warning letter late last year regarding rec0rd-keeping and quality-control violations at a Texas plant.
Steris’ share price was down about 1.5 percent to $34.16 in late trading Tuesday.