FDA inspection
EKO Devices, Inc.: FDA inspection ending Aug 30, 2019
FDA inspection 1141472 · Voluntary Action Indicated (VAI) · Oakland, CA
Key facts
| Inspection ID | 1141472 |
|---|---|
| Firm | EKO Devices, Inc. |
| FEI number | 3011651230 |
| Address | 1212 Broadway Ste 100 |
| City | Oakland |
| State | CA |
| ZIP | 94612-1835 |
| Fiscal year | 2019 |
| Inspection end date | Aug 30, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None 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