FDA inspection
Konan Medical Inc.: FDA inspection ending Jul 28, 2016
FDA inspection 984088 · Voluntary Action Indicated (VAI) · Nishinomiya
Key facts
| Inspection ID | 984088 |
|---|---|
| Firm | Konan Medical Inc. |
| FEI number | 1000494121 |
| Address | 10-29, Miyanishi-Cho |
| City | Nishinomiya |
| Country | Japan |
| Fiscal year | 2016 |
| Inspection end date | Jul 28, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| 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