Warning letter
iRhythm Technologies, Inc.: warning letter of May 25, 2023
FDA warning letter 643474 · Center for Devices and Radiological Health
Key facts
| Reference number | 643474 |
|---|---|
| Company | iRhythm Technologies, Inc. |
| Subject | Medical Devices/Adulterated/Quality System Regulation (QSR) |
| Issue date | May 25, 2023 |
| Posted date | Jun 6, 2023 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803.17(a)(1), 803.17(a)(3), 803.50(a)(1), 803.50(a)(2), 820, 807.81(b), 803.50(a), 801, 801.5, 801.109, 803, 803.3 and 3 more |
| Inspection city | Cypress |
| Inspection ZIP | 90630 |
| Inspection start date | Jul 25, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: