FDA inspection
Elekta, Inc.: FDA inspection ending Sep 28, 2009
FDA inspection 616125 · Voluntary Action Indicated (VAI) · Sunnyvale, CA
Key facts
| Inspection ID | 616125 |
|---|---|
| Firm | Elekta, Inc. |
| FEI number | 1000123805 |
| Address | 100 Mathilda Pl, 5th Floor |
| City | Sunnyvale |
| State | CA |
| ZIP | 94086 |
| Country | United States |
| Fiscal year | 2009 |
| Inspection end date | Sep 28, 2009 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- 1–9 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