FDA inspection
HemoCue AB: FDA inspection ending Oct 26, 2011
FDA inspection 750673 · Voluntary Action Indicated (VAI) · Angelholm
Key facts
| Inspection ID | 750673 |
|---|---|
| Firm | HemoCue AB |
| FEI number | 3003044483 |
| Address | Kuvettgatan 1 |
| City | Angelholm |
| Country | Sweden |
| Fiscal year | 2012 |
| Inspection end date | Oct 26, 2011 |
| 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