FDA inspection
Gambro Renal Products S.A. de C.V.: FDA inspection ending Feb 19, 2009
FDA inspection 570585 · Official Action Indicated (OAI) · Tijuana
Key facts
| Inspection ID | 570585 |
|---|---|
| Firm | Gambro Renal Products S.A. de C.V. |
| FEI number | 3002806727 |
| Address | Blvd. Pacifico 10014,, Parque Industrial Pacifico |
| City | Tijuana |
| Country | Mexico |
| Fiscal year | 2009 |
| Inspection end date | Feb 19, 2009 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 64043 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes 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