FDA inspection
ICU Medical de Mexico, S.A. de C.V.: FDA inspection ending Feb 18, 2016
FDA inspection 962188 · Voluntary Action Indicated (VAI) · Ensenada
Key facts
| Inspection ID | 962188 |
|---|---|
| Firm | ICU Medical de Mexico, S.A. de C.V. |
| FEI number | 3003807466 |
| Address | Avenida Cuarzo 250, Ensenada |
| City | Ensenada |
| Country | Mexico |
| Fiscal year | 2016 |
| Inspection end date | Feb 18, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 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