FDA inspection
Flowonix Medical Inc: FDA inspection ending Oct 11, 2019
FDA inspection 1106236 · Voluntary Action Indicated (VAI) · Mansfield, MA
Key facts
| Inspection ID | 1106236 |
|---|---|
| Firm | Flowonix Medical Inc |
| FEI number | 3010079947 |
| Address | 120 Forbes Blvd Ste 170 |
| City | Mansfield |
| State | MA |
| ZIP | 02048 |
| Country | United States |
| Fiscal year | 2020 |
| Inspection end date | Oct 11, 2019 |
| 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
- Yes 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