FDA inspection
Ortek AG: FDA inspection ending Apr 15, 2004
FDA inspection 326561 · Official Action Indicated (OAI) · Merenschwand
Key facts
| Inspection ID | 326561 |
|---|---|
| Firm | Ortek AG |
| FEI number | 3003061090 |
| Address | Industrie Nord 5 |
| City | Merenschwand |
| Fiscal year | 2004 |
| Inspection end date | Apr 15, 2004 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Med Devices |
| Product type | Devices |
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