FDA 483 - iRhythm Technologies, Inc. - July 31, 2024

iRhythm Technologies, Inc., a medical device manufacturer, underwent an FDA inspection from July 15-31, 2024, revealing significant deficiencies in its quality system. The observations, documented in a Form FDA-483, point to non-compliance with regulatory requirements related to complaint handling, process controls, and statistical techniques.

Aprimary finding highlighted the company’s inadequate procedures for receiving, reviewing, and evaluating complaints, especially concerning skin irritations and abrasions from the Zio XT device. The FDA noted a failure to establish written protocols for these complaints, leading to a lack of corrective and preventive actions or impact assessments despite numerous instances breaching control limits. Additionally, the firm did not consistently categorize complaints, perform required searches for misclassified events, or record them promptly.

Further issues included the absence of adequate process control procedures for calculating algorithm sensitivity levels for the ZEUS Performance Metrics device, with no documented evaluation of 2023 sensitivity levels. Lastly, the company lacked established procedures for identifying valid statistical techniques for product characteristic verification, specifically for the abrader disc component's receiving inspection sample size. iRhythm Technologies is required to implement comprehensive corrective actions, developing and maintaining robust procedures to ensure full adherence to medical device quality system regulations.