FDA inspection
Lutronic Corporation: FDA inspection ending Oct 29, 2015
FDA inspection 954813 · Voluntary Action Indicated (VAI) · Goyang
Key facts
| Inspection ID | 954813 |
|---|---|
| Firm | Lutronic Corporation |
| FEI number | 3004483538 |
| Address | 219 Sowon-Ro; Deogyang |
| City | Goyang |
| Country | Korea (the Republic of) |
| Fiscal year | 2016 |
| Inspection end date | Oct 29, 2015 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- 1–9 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