FDA Inspection
iRhythm Technologies InciRhythm Technologies Inc – FDA Inspection, Jul 31, 2024
Record Details
This FDA Inspection record concerns iRhythm Technologies Inc, with an inspection on July 31, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bee72d5f-6c26-4e0f-b651-273d18bd14ff
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1245190
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
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Other FDA inspections of iRhythm Technologies Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 29, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 28, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 14, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for iRhythm Technologies Inc
- FDA Inspection 976467 - 2016-06-29
- FDA Inspection 820317 - 2013-02-28
- FDA Inspection 701878 - 2010-12-14
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