FDA inspectors concluded their assessment of iRhythm’s facility in Cypress, Calif. in August 2022. The FDA visit led to a Form 483 later that month. iRhythm took steps to address the concerns raised in the 483 but its actions failed to stop the FDA from escalating the situation. The FDA sent a warning letter to the company last week, iRhythm said in a filing with the Securities and Exchange Commission. The FDA has yet to publish the notice online.
iRhythm provided a brief overview of the problems identified by the FDA, but full details will only emerge once the letter is published. The company plans to take “appropriate action to further address the 483 observations and other items identified in the warning letter with respect to the Zio AT System.”
