Warning letter
Insightra Medical Inc.: warning letter of Jun 3, 2025
FDA warning letter 706921 · Center for Devices and Radiological Health
Key facts
| Reference number | 706921 |
|---|---|
| Company | Insightra Medical Inc. |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | Jun 3, 2025 |
| Posted date | Jul 8, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 806.10(a), 806.10(b), 803, 803.3, 803.17, 803.17(a)(1), 803.50(a)(1), 803.50(a)(2), 806, 806.10, 807.81(a)(3)(ii) |
| Inspection city | Clarksville |
| Inspection ZIP | 37043 |
| Inspection start date | Jan 21, 2025 |
| 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: