FDA inspection
Otsuka Pharmaceutical Co., Ltd.: FDA inspection ending Oct 10, 2025
FDA inspection 1291346 · No Action Indicated (NAI) · Itano-Gun
Key facts
| Inspection ID | 1291346 |
|---|---|
| Firm | Otsuka Pharmaceutical Co., Ltd. |
| FEI number | 3003656524 |
| Address | Minami, Shishitoki, Matsutani, 13; Itano-Cho |
| City | Itano-Gun |
| Country | Japan |
| Fiscal year | 2026 |
| Inspection end date | Oct 10, 2025 |
| Classification | No Action Indicated (NAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- None Citations
- None Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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