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Facility Inspection Leads To FDA Warning For iRhythm

 
• By Brian Bossetta

The US FDA issued a warning letter to iRhythm Technologies related to its Zio cardiac monitor system after an August 2022 inspection of the firm’s California facility. Wells Fargo predicts little impact on the company.

Warning
• Source: Shutterstock

The Food and Drug Administration sent iRhythm Technologies a warning letter on 25 May alleging “non-conformities to regulations for medical devices, including medical device reporting requirements, relating to the Zio AT System and medical device quality system requirements” according to an 8-K report the company filed with the US Securities and Exchange Commission (SEC).

The FDA’s letter resulted from an inspection of the company’s facility located in Cypress, CA that concluded last August, though iRhythm said that it does not restrict manufacturing, production, or shipment of any of the company’s products or require the

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