Warning letter
ExThera Medical Corporation: warning letter of Feb 6, 2026
FDA warning letter 715068 · Center for Devices and Radiological Health
Key facts
| Reference number | 715068 |
|---|---|
| Company | ExThera Medical Corporation |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Feb 6, 2026 |
| Posted date | Feb 24, 2026 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.81, 807.81(b), 812, 812.5(b), 812.7, 812.35(a)(1), 812.35(a)(2), 812.40, 812.46(a) |
| Inspection city | Martinez |
| Inspection ZIP | 94553 |
| Inspection start date | May 27, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
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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: