Warning letter
Envoy Medical Inc.: warning letter of Nov 11, 2025
FDA warning letter 718762 · Center for Devices and Radiological Health
Key facts
| Reference number | 718762 |
|---|---|
| Company | Envoy Medical Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Nov 11, 2025 |
| Posted date | Dec 9, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Saint Paul |
| Inspection ZIP | 55110 |
| Inspection start date | Jun 24, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 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: