FDA inspection
Janssen Biologics B.V.: FDA inspection ending Oct 30, 2003
FDA inspection 305048 · Voluntary Action Indicated (VAI) · Leiden
Key facts
| Inspection ID | 305048 |
|---|---|
| Firm | Janssen Biologics B.V. |
| FEI number | 3002806632 |
| Address | Einsteinweg 101 |
| City | Leiden |
| Fiscal year | 2004 |
| Inspection end date | Oct 30, 2003 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- None 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