FDA inspection
Cochlear Americas Inc.: FDA inspection ending Oct 19, 2006
FDA inspection 448628 · Official Action Indicated (OAI) · Lone Tree, CO
Key facts
| Inspection ID | 448628 |
|---|---|
| Firm | Cochlear Americas Inc. |
| FEI number | 3005900820 |
| Address | 10350 Park Meadows Dr |
| City | Lone Tree |
| State | CO |
| ZIP | 80124-6800 |
| Fiscal year | 2007 |
| Inspection end date | Oct 19, 2006 |
| Classification | Official Action Indicated (OAI) |
| Project area | Product Evaluation: Med Devices |
| Product type | Devices |
| Warning letter | UCM076322 |
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
- 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