FDA inspection
de Gotzen S.r.l.: FDA inspection ending Dec 21, 2017
FDA inspection 1037479 · Official Action Indicated (OAI) · Olgiate Olona
Key facts
| Inspection ID | 1037479 |
|---|---|
| Firm | de Gotzen S.r.l. |
| FEI number | 3002994636 |
| Address | Via Roma 45 |
| City | Olgiate Olona |
| Country | Italy |
| Fiscal year | 2018 |
| Inspection end date | Dec 21, 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