FDA inspection
Konan Medical USA Inc: FDA inspection ending Nov 28, 2018
FDA inspection 1098226 · Voluntary Action Indicated (VAI) · Irvine, CA
Key facts
| Inspection ID | 1098226 |
|---|---|
| Firm | Konan Medical USA Inc |
| FEI number | 3005955744 |
| Address | 15770 Laguna Canyon Rd Ste 150 |
| City | Irvine |
| State | CA |
| ZIP | 92618-3141 |
| Fiscal year | 2019 |
| Inspection end date | Nov 28, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Medical 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