FDA inspection
Cogentix Medical, Inc.: FDA inspection ending Apr 14, 2022
FDA inspection 1167401 · Voluntary Action Indicated (VAI) · Orangeburg, NY
Key facts
| Inspection ID | 1167401 |
|---|---|
| Firm | Cogentix Medical, Inc. |
| FEI number | 2242464 |
| Address | 40 Ramland Rd S |
| City | Orangeburg |
| State | NY |
| ZIP | 10962 |
| Country | United States |
| Fiscal year | 2022 |
| Inspection end date | Apr 14, 2022 |
| 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