FDA inspection
Elcam Medical Italy SPA: FDA inspection ending Sep 22, 2011
FDA inspection 747430 · Official Action Indicated (OAI) · Carpi
Key facts
| Inspection ID | 747430 |
|---|---|
| Firm | Elcam Medical Italy SPA |
| FEI number | 3004960482 |
| Address | Via Emilia Romagna 15 |
| City | Carpi |
| Country | Italy |
| Fiscal year | 2011 |
| Inspection end date | Sep 22, 2011 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 257195 |
At a glance
- 1–9 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