FDA inspection
Unetixs Vascular, Inc.: FDA inspection ending Oct 29, 2019
FDA inspection 1107891 · Official Action Indicated (OAI) · Warwick, RI
Key facts
| Inspection ID | 1107891 |
|---|---|
| Firm | Unetixs Vascular, Inc. |
| FEI number | 1222117 |
| Address | 125 Commerce Park Rd |
| City | Warwick |
| State | RI |
| ZIP | 02886 |
| Country | United States |
| Fiscal year | 2020 |
| Inspection end date | Oct 29, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 598016 |
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