FDA inspection
ICU Medical Costa Rica Ltd.: FDA inspection ending Apr 19, 2012
FDA inspection 780800 · Official Action Indicated (OAI) · Heredia
Key facts
| Inspection ID | 780800 |
|---|---|
| Firm | ICU Medical Costa Rica Ltd. |
| FEI number | 3002999813 |
| Address | La Aurora De Heredia,1 Km Noreste Del Centro Comercial, Real Cariari, ZONA FRANCA GLOBAL Park De Entrada 300 |
| City | Heredia |
| Country | Costa Rica |
| Fiscal year | 2012 |
| Inspection end date | Apr 19, 2012 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 331698 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes 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