FDA inspection
Sysmex America, Inc.: FDA inspection ending Oct 26, 2007
FDA inspection 492891 · Voluntary Action Indicated (VAI) · Mundelein, IL
Key facts
| Inspection ID | 492891 |
|---|---|
| Firm | Sysmex America, Inc. |
| FEI number | 1000515253 |
| Address | 1 Sysmex Way |
| City | Mundelein |
| State | IL |
| ZIP | 60060-9528 |
| Fiscal year | 2008 |
| Inspection end date | Oct 26, 2007 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Med 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