FDA inspection
Koios Medical, Inc.: FDA inspection ending May 13, 2021
FDA inspection 1142629 · Voluntary Action Indicated (VAI) · New York, NY
Key facts
| Inspection ID | 1142629 |
|---|---|
| Firm | Koios Medical, Inc. |
| FEI number | 3010119782 |
| Address | 242 W 38th St Fl 14 |
| City | New York |
| State | NY |
| ZIP | 10018 |
| Country | United States |
| Fiscal year | 2021 |
| Inspection end date | May 13, 2021 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: 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