FDA inspection
AXENA HEALTH, INC.: FDA inspection ending Nov 14, 2018
FDA inspection 1071637 · Voluntary Action Indicated (VAI) · Auburndale, MA
Key facts
| Inspection ID | 1071637 |
|---|---|
| Firm | AXENA HEALTH, INC. |
| FEI number | 3026585193 |
| Address | 263 Summer St Fl 5 |
| City | Auburndale |
| State | MA |
| ZIP | 02466 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Nov 14, 2018 |
| 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