FDA inspection
Irvine Biomedical Inc, a St. Jude Medical Co.: FDA inspection ending Nov 19, 2015
FDA inspection 948311 · Voluntary Action Indicated (VAI) · Irvine, CA
Key facts
| Inspection ID | 948311 |
|---|---|
| Firm | Irvine Biomedical Inc, a St. Jude Medical Co. |
| FEI number | 1000519796 |
| Address | 2375 and 2382 Morse Ave |
| City | Irvine |
| State | CA |
| ZIP | 92614 |
| Country | United States |
| Fiscal year | 2016 |
| Inspection end date | Nov 19, 2015 |
| 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
- 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