Warning letter
Amedica Corporation [ARCHIVED]: warning letter of Jan 27, 2009
FDA warning letter 46458 · Center for Devices and Radiological Health
Key facts
| Reference number | 46458 |
|---|---|
| Company | Amedica Corporation [ARCHIVED] |
| Subject | Premarket Approval/Adulterated |
| Issue date | Jan 27, 2009 |
| Posted date | Jan 27, 2009 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.81, 807.81(b) |
| Inspection city | Salt Lake City |
| Inspection ZIP | 84119-1303 |
| Inspection start date | Aug 7, 2008 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- NAI 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: