FDA inspection
Abbott Diagnostics International, Ltd.: FDA inspection ending Dec 1, 2008
FDA inspection 551073 · Voluntary Action Indicated (VAI) · Barceloneta, PR
Key facts
| Inspection ID | 551073 |
|---|---|
| Firm | Abbott Diagnostics International, Ltd. |
| FEI number | 2623532 |
| Address | Carr # 2 Km 58.0 |
| City | Barceloneta |
| State | PR |
| ZIP | 00617 |
| Fiscal year | 2009 |
| Inspection end date | Dec 1, 2008 |
| Classification | Voluntary Action Indicated (VAI) |
| 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