FDA inspection
Cochlear Americas Inc.: FDA inspection ending Feb 22, 2018
FDA inspection 1042149 · Official Action Indicated (OAI) · Lone Tree, CO
Key facts
| Inspection ID | 1042149 |
|---|---|
| Firm | Cochlear Americas Inc. |
| FEI number | 3005900820 |
| Address | 10350 Park Meadows Dr |
| City | Lone Tree |
| State | CO |
| ZIP | 80124 |
| Country | United States |
| Fiscal year | 2018 |
| Inspection end date | Feb 22, 2018 |
| Classification | Official Action Indicated (OAI) |
| Project area | Bioresearch Monitoring |
| 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
- 10–99 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