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

iRhythm Technologies, Inc. in Cypress, CA, a medical device manufacturer, was cited for significant deficiencies in its quality system. The inspection revealed inadequate complaint handling procedures, including failures to investigate skin irritation complaints and properly record all complaints. Additionally, the firm lacked established procedures for calculating and monitoring algorithm sensitivity levels and for using valid statistical techniques in receiving inspections.