Warning letter
Spinal Elements, Inc: warning letter of Jun 12, 2014
FDA warning letter 421804 · Los Angeles District Office
Key facts
| Reference number | 421804 |
|---|---|
| Company | Spinal Elements, Inc |
| Subject | Premarket Approval/Misbranded/Adulterated |
| Issue date | Jun 12, 2014 |
| Posted date | Jun 12, 2014 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 807.81(b) |
| Inspection city | Carlsbad |
| Inspection ZIP | 92010 |
| Inspection start date | Jan 6, 2014 |
| 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: