FDA inspection
Ophtec BV: FDA inspection ending Mar 23, 2017
FDA inspection 1008948 · Official Action Indicated (OAI) · Groningen
Key facts
| Inspection ID | 1008948 |
|---|---|
| Firm | Ophtec BV |
| FEI number | 3002501070 |
| Address | Schweitzerlaan 15 |
| City | Groningen |
| Country | Netherlands |
| Fiscal year | 2017 |
| Inspection end date | Mar 23, 2017 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: 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