FDA inspection
Agile Devices, Inc.: FDA inspection ending Feb 20, 2026
FDA inspection 1303582 · Voluntary Action Indicated (VAI) · Newton Center, MA
Key facts
| Inspection ID | 1303582 |
|---|---|
| Firm | Agile Devices, Inc. |
| FEI number | 3023167283 |
| Address | 1087 Beacon St Ste 302 |
| City | Newton Center |
| State | MA |
| ZIP | 02459 |
| Country | United States |
| Fiscal year | 2026 |
| Inspection end date | Feb 20, 2026 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- 1–9 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