FDA inspection
Enraf-Nonius B.V.: FDA inspection ending Mar 27, 2013
FDA inspection 827610 · Official Action Indicated (OAI) · Rotterdam
Key facts
| Inspection ID | 827610 |
|---|---|
| Firm | Enraf-Nonius B.V. |
| FEI number | 3002806913 |
| Address | Vareseweg 127 |
| City | Rotterdam |
| Country | Netherlands |
| Fiscal year | 2013 |
| Inspection end date | Mar 27, 2013 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 398439 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- Yes 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