FDA inspection
Elekta Instrument AB: FDA inspection ending Sep 26, 2019
FDA inspection 1122097 · No Action Indicated (NAI) · Stockholm
Key facts
| Inspection ID | 1122097 |
|---|---|
| Firm | Elekta Instrument AB |
| FEI number | 3002806883 |
| Address | Kungstensgatan 18 |
| City | Stockholm |
| Fiscal year | 2019 |
| Inspection end date | Sep 26, 2019 |
| Classification | No Action Indicated (NAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None Citations
- None Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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