FDA inspection
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution: FDA inspection ending Mar 31, 2016
FDA inspection 969856 · Voluntary Action Indicated (VAI) · Haltom City, TX
Key facts
| Inspection ID | 969856 |
|---|---|
| Firm | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution |
| FEI number | 1625507 |
| Address | 4620 N Beach St |
| City | Haltom City |
| State | TX |
| ZIP | 76137-3219 |
| Fiscal year | 2016 |
| Inspection end date | Mar 31, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None Citations
- 1–9 Posted citations
- No 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