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

Source: https://www.keypedia.com/records/483/irhythm-technologies-inc/0fcd49d0-47ef-4096-8d06-42760cad2e81

> FDA 483 for iRhythm Technologies, Inc. on July 31, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: iRhythm Technologies, Inc.
- Inspection Date: 2024-07-31
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Documents

- [483 - 2022-08-12](https://www.keypedia.com/records/483/irhythm-technologies-inc/1f6b9f5b-915b-46ab-9ce1-83f72a64f8ce)
- [483 - 2024-07-31](https://www.keypedia.com/records/483/irhythm-technologies-inc/848b713d-9e33-4cc1-b651-5d975c2320f3)

## Related Officers

- [Katlin N. Stubbs](https://www.keypedia.com/people/katlin-n-stubbs/27d70db1-a2e9-4254-a721-c6de655f7626)
- [James R. Montero](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.keypedia.com/companies/irhythm-technologies-inc/22726654-c3a7-4b3b-9cc8-9d0032796ab3

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6