FDA inspection
Orthofix, Inc: FDA inspection ending Oct 18, 2007
FDA inspection 494032 · No Action Indicated (NAI) · Lewisville, TX
Key facts
| Inspection ID | 494032 |
|---|---|
| Firm | Orthofix, Inc |
| FEI number | 2183449 |
| Address | 3451 Plano Pkwy |
| City | Lewisville |
| State | TX |
| ZIP | 75056-9453 |
| Fiscal year | 2008 |
| Inspection end date | Oct 18, 2007 |
| Classification | No Action Indicated (NAI) |
| Project area | Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics, Drugs |
At a glance
- None Citations
- None Posted citations
- No 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