The agency inspected the company’s Cypress, Calif., facility in August, according to a May 25 Securities and Exchange Commission document. iRhythm attempted to correct the issues, but as of May the FDA was not satisfied. The agency alleged “nonconformities to regulations for medical devices, including medical device reporting requirements, relating to the company’s Zio AT System and medical device quality system requirements,” the letter said. The full details of the problem have not yet been released by the FDA.
The warning does not restrict the manufacture and sale of iRhythm’s products and does not require a recall.
“The company takes these matters very seriously,” the letter said. “The company intends to respond within the specified time period and work diligently to address the FDA’s concerns.”
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