FDA inspection
Densply Sirona Orthodontics Inc.: FDA inspection ending Nov 18, 2016
FDA inspection 1003043 · Voluntary Action Indicated (VAI) · Sarasota, FL
Key facts
| Inspection ID | 1003043 |
|---|---|
| Firm | Densply Sirona Orthodontics Inc. |
| FEI number | 1036212 |
| Address | 7290 26th Ct E |
| City | Sarasota |
| State | FL |
| ZIP | 34243-3963 |
| Fiscal year | 2017 |
| Inspection end date | Nov 18, 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