FDA inspection
Abbott Diagnostics International, Ltd.: FDA inspection ending Jun 17, 2009
FDA inspection 594663 · Voluntary Action Indicated (VAI) · Barceloneta, PR
Key facts
| Inspection ID | 594663 |
|---|---|
| Firm | Abbott Diagnostics International, Ltd. |
| FEI number | 2623532 |
| Address | Carr # 2 Km 58.0 |
| City | Barceloneta |
| State | PR |
| ZIP | 00617 |
| Country | United States |
| Fiscal year | 2009 |
| Inspection end date | Jun 17, 2009 |
| 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