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iRhythm receives FDA warning letter on California plant inspection

May 30, 2023 4:50 PM ETiRhythm Technologies, Inc. (IRTC)By: Jonathan Block, SA News Editor
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  • The US FDA has issued a warning letter to iRhythm Technologies (NASDAQ:IRTC) related to an inspection of a Cypress, Calif., facility.
  • The agency is alleging non-conformities to medical device regulations related to iRhythm's (IRTC) Zio AT System and medical device quality system requirements.
  • The company said it will work with the FDA to address the concerns.

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