Warning letter
Cochlear Americas: warning letter of Mar 13, 2007
FDA warning letter UCM076322 · Center for Devices and Radiological Health
Key facts
| Reference number | UCM076322 |
|---|---|
| Company | Cochlear Americas |
| Subject | Investigational Device Exemptions (Sponsor) |
| Issue date | Mar 13, 2007 |
| Posted date | Mar 13, 2007 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 812.40, 812.25(e), 812.140(b)(2), 812.43(c) |
| Country | 3 |
| Inspection city | Lone Tree |
| Inspection ZIP | 80124-6800 |
| Inspection start date | Oct 11, 2006 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: