Warning letter
LifeVac, LLC: warning letter of Sep 18, 2025
FDA warning letter 713455 · Center for Devices and Radiological Health
Key facts
| Reference number | 713455 |
|---|---|
| Company | LifeVac, LLC |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Sep 18, 2025 |
| Posted date | Oct 14, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| Country | 1 |
| Letter on fda.gov | fda.gov |
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: