FDA inspection
Orthoton BV: FDA inspection ending Mar 2, 2004
FDA inspection 318415 · Official Action Indicated (OAI) · Gorinchem
Key facts
| Inspection ID | 318415 |
|---|---|
| Firm | Orthoton BV |
| FEI number | 3002989352 |
| Address | Avelingen-West 27c |
| City | Gorinchem |
| Fiscal year | 2004 |
| Inspection end date | Mar 2, 2004 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Med Devices |
| Product type | Devices |
| Warning letter | UCM146862 |
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