Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma Co., Ltd. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jul 11, 2025 · VAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 11, 2025 | Oita, Japan | Drugs | Voluntary Action Indicated (VAI) | 3005619533 |
| Apr 16, 2019 | Oita, Japan | Drugs | Voluntary Action Indicated (VAI) | 3005619533 |
| Feb 17, 2017 | Oita, Japan | Drugs | Voluntary Action Indicated (VAI) | 3005619533 |
| Sep 12, 2014 | Oita, Japan | Drugs | Voluntary Action Indicated (VAI) | 3005619533 |
| Feb 24, 2012 | Oita, Japan | Drugs | Voluntary Action Indicated (VAI) | 3005619533 |
| Jul 30, 2010 | Oita, Japan | Drugs | Voluntary Action Indicated (VAI) | 3005619533 |
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3005619533 | Oita, Japan | 6 | Jul 11, 2025 |