FDA 483 - iRhythm Technologies Inc - July 31, 2024

The FDA inspection of the facility identified significant deficiencies across multiple quality system areas, particularly concerning corrective and preventive actions (CAPA), risk analysis, and Medical Device Reporting (MDR).

**Facility and Operation Details:** The inspection pertains to operations involving Certified Cardiographic Technician (CCT) personnel and medical devices including Zio AT, Zio XT, Zio Monitor, and Zeus System Software. CCT personnel review and interpret cardiographic and arrhythmia data for diagnosis.

**Violations and Observations:**

* **Observation 1: Inadequate CAPA Procedures (SOP0020 Rev 12, DOP0333 Rev 01).** * The firm failed to adequately analyze approximately 4,014 complaints (05/02/2022 - 07/19/2024) related to CCT personnel misreading arrhythmia data, which led to misclassified data for diagnosis. * No CAPA or health hazard evaluation was initiated, nor was a risk analysis performed for these recurring quality problems. * The firm's quality metric calculations ([(b) (4)]) are not all-inclusive due to missing relevant data inputs. * A plan implemented around 07/02/2024 to not report algorithm misread/misinterpretation events as malfunctions under 21 CFR § 803 lacks established procedures for retroactive or