FDA inspection
Spinal Elements, Inc: FDA inspection ending Jan 15, 2014
FDA inspection 863246 · Official Action Indicated (OAI) · Carlsbad, CA
Key facts
| Inspection ID | 863246 |
|---|---|
| Firm | Spinal Elements, Inc |
| FEI number | 3004893332 |
| Address | 3115 Melrose Dr Ste 200 |
| City | Carlsbad |
| State | CA |
| ZIP | 92010 |
| Country | United States |
| Fiscal year | 2014 |
| Inspection end date | Jan 15, 2014 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 421804 |
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
- 1–9 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