FDA inspection
Kaken Pharmaceutical Co., Ltd.: FDA inspection ending Jun 22, 2018
FDA inspection 1056547 · Voluntary Action Indicated (VAI) · Fujieda
Key facts
| Inspection ID | 1056547 |
|---|---|
| Firm | Kaken Pharmaceutical Co., Ltd. |
| FEI number | 3002807376 |
| Address | Kakenseiyaku (Kabu) Shizuokakojo, 301; Gensuke; Gensuke; Gensuke; Gensuke; Gensuke; Gensuke |
| City | Fujieda |
| Country | Japan |
| Fiscal year | 2018 |
| Inspection end date | Jun 22, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
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