FDA inspection
ICU Medical, Inc.: FDA inspection ending Feb 7, 2013
FDA inspection 818394 · Official Action Indicated (OAI) · Lake Forest, IL
Key facts
| Inspection ID | 818394 |
|---|---|
| Firm | ICU Medical, Inc. |
| FEI number | 3013319212 |
| Address | 600 N Field Dr |
| City | Lake Forest |
| State | IL |
| ZIP | 60045 |
| Country | United States |
| Fiscal year | 2013 |
| Inspection end date | Feb 7, 2013 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 394420 |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 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