FDA inspection
Denka Co. Ltd.: FDA inspection ending May 23, 2024
FDA inspection 1241642 · Voluntary Action Indicated (VAI) · Gosen
Key facts
| Inspection ID | 1241642 |
|---|---|
| Firm | Denka Co. Ltd. |
| FEI number | 3003871639 |
| Address | 1359-1, Minamihon-Cho |
| City | Gosen |
| Country | Japan |
| Fiscal year | 2024 |
| Inspection end date | May 23, 2024 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: 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