FDA inspection
Shofu Inc.: FDA inspection ending May 24, 2018
FDA inspection 1055380 · Voluntary Action Indicated (VAI) · Kyoto
Key facts
| Inspection ID | 1055380 |
|---|---|
| Firm | Shofu Inc. |
| FEI number | 3002808149 |
| Address | 11 Kamitakamatsu-Cho, Fukuine, Higashiyama-Ku |
| City | Kyoto |
| Country | Japan |
| Fiscal year | 2018 |
| Inspection end date | May 24, 2018 |
| 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