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# iRhythm Hit With 2nd FDA-483 in a Month
- URL: https://www.fdaweb.com/irhythm-hit-with-2nd-fda-483-in-a-month/
- Published: 2024-08-26T12:00:00.000Z
- Updated: 2026-09-14T14:39:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157652

FDA has escalated its surveillance of iRhythm Technologies based on a [second Form FDA-483](https://www.fda.gov/media/181269/download?ref=fdaweb.com) issued last month at the company’s Cypress, CA manufacturing facility that was simultaneously inspected with its San Francisco facility, which also ended with an FDA-483 ([see earlier story](https://www.fdaweb.com/irhythm-hit-with-483-after-july-inspection/)). Presumably, the inspections are related to the company’s ongoing issues raised in a [Warning Letter](https://fdaweb.com/login.php?sa=v&aid=D5154623&cate=&stid=%241%24ub..fi%2F.%24AwSq5L%2FRHR7ICUildEg1w1&ref=fdaweb.com) last year that it has been working to resolve.

The Warning Letter determined that the company’s ZIO AT system was an unapproved device because it was cleared for long-term monitoring of arrhythmia events for non-critical care patients, but marketing materials describe different indications with changes to the device that would require a new 510(k) submission. The letter also addressed labeling violations and these Quality System Regulation violations:

- failing to adequately establish and maintain procedures for implementing corrective and preventive action;
- failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; and
- failing to validate a process to a high degree of assurance.

The latest inspection at the Cypress facility cited the firm for not adequately establishing procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. FDA investigators also cited iRhythm over not adequately establishing its process control procedures and procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics.