FDA inspection
Fresenius Kabi iPSUM Srl: FDA inspection ending Dec 15, 2009
FDA inspection 638402 · Official Action Indicated (OAI) · Villadose
Key facts
| Inspection ID | 638402 |
|---|---|
| Firm | Fresenius Kabi iPSUM Srl |
| FEI number | 3005479678 |
| Address | Via San Leonardo 23 |
| City | Villadose |
| Country | Italy |
| Fiscal year | 2010 |
| Inspection end date | Dec 15, 2009 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 112568 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes 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