FDA inspection
Able Medical Devices: FDA inspection ending Mar 21, 2025
FDA inspection 1265671 · Voluntary Action Indicated (VAI) · Gwinn, MI
Key facts
| Inspection ID | 1265671 |
|---|---|
| Firm | Able Medical Devices |
| FEI number | 3014680795 |
| Address | 512 4th St |
| City | Gwinn |
| State | MI |
| ZIP | 49841 |
| Country | United States |
| Fiscal year | 2025 |
| Inspection end date | Mar 21, 2025 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- None Citations
- 1–9 Posted citations
- No 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