FDA inspection
Biotika a.s.: FDA inspection ending Dec 13, 2007
FDA inspection 501186 · Voluntary Action Indicated (VAI) · Slovenska Lupca
Key facts
| Inspection ID | 501186 |
|---|---|
| Firm | Biotika a.s. |
| FEI number | 3003370212 |
| Address | Slovenska Lupca 566 |
| City | Slovenska Lupca |
| Fiscal year | 2008 |
| Inspection end date | Dec 13, 2007 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Generic Drug Evaluation |
| Product type | Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 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