FDA inspection
Akorn Operating Company LLC: FDA inspection ending Nov 12, 2003
FDA inspection 301238 · Voluntary Action Indicated (VAI) · Somerset, NJ
Key facts
| Inspection ID | 301238 |
|---|---|
| Firm | Akorn Operating Company LLC |
| FEI number | 2246848 |
| Address | 72 Veronica Ave |
| City | Somerset |
| State | NJ |
| ZIP | 08873-3426 |
| Fiscal year | 2004 |
| Inspection end date | Nov 12, 2003 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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