FDA inspection
Alphatec Spine, Inc.: FDA inspection ending Mar 13, 2015
FDA inspection 917997 · Official Action Indicated (OAI) · Carlsbad, CA
Key facts
| Inspection ID | 917997 |
|---|---|
| Firm | Alphatec Spine, Inc. |
| FEI number | 2027467 |
| Address | 5830 El Camino Real |
| City | Carlsbad |
| State | CA |
| ZIP | 92008 |
| Country | United States |
| Fiscal year | 2015 |
| Inspection end date | Mar 13, 2015 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 461526 |
At a glance
- None 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