FDA inspection
Envoy Medical Corporation: FDA inspection ending Jul 2, 2025
FDA inspection 1276707 · Official Action Indicated (OAI) · Saint Paul, MN
Key facts
| Inspection ID | 1276707 |
|---|---|
| Firm | Envoy Medical Corporation |
| FEI number | 3004007782 |
| Address | 4875 White Bear Pkwy |
| City | Saint Paul |
| State | MN |
| ZIP | 55110 |
| Country | United States |
| Fiscal year | 2025 |
| Inspection end date | Jul 2, 2025 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 718762 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data