FDA inspection
Otsuka ICU Medical LLC: FDA inspection ending May 23, 2014
FDA inspection 880543 · Voluntary Action Indicated (VAI) · Austin, TX
Key facts
| Inspection ID | 880543 |
|---|---|
| Firm | Otsuka ICU Medical LLC |
| FEI number | 1628454 |
| Address | 3900 Howard Ln |
| City | Austin |
| State | TX |
| ZIP | 78728 |
| Country | United States |
| Fiscal year | 2014 |
| Inspection end date | May 23, 2014 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- 10–99 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