Sumitomo Chemical Co., Ltd.
Sumitomo Chemical Co., Ltd. has 0 FDA recalls, 16 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest inspection
- Oct 31, 2025 · VAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 16 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 2 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 2 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 31, 2025 | Anpachi-Gun, Japan | Drugs | Voluntary Action Indicated (VAI) | 3002808125 |
| Nov 10, 2023 | Osaka, Japan | Drugs | No Action Indicated (NAI) | 3002808126 |
| Nov 2, 2023 | Kurashiki, Japan | Drugs | No Action Indicated (NAI) | 3003973514 |
| Sep 6, 2019 | Anpachi-Gun, Japan | Drugs | Voluntary Action Indicated (VAI) | 3002808125 |
| Feb 8, 2019 | Oita, Japan | Drugs | No Action Indicated (NAI) | 3002808279 |
| Dec 8, 2017 | Anpachi-Gun, Japan | Drugs | Voluntary Action Indicated (VAI) | 3002808125 |
| Sep 23, 2016 | Anpachi-Gun, Japan | Drugs | Voluntary Action Indicated (VAI) | 3002808125 |
| Jul 22, 2016 | Osaka, Japan | Drugs | No Action Indicated (NAI) | 3002808126 |
| Jul 15, 2016 | Kurashiki, Japan | Drugs | Voluntary Action Indicated (VAI) | 3003973514 |
| Apr 22, 2016 | Oita, Japan | Drugs | Voluntary Action Indicated (VAI) | 3002808279 |
| Mar 14, 2014 | Anpachi-Gun, Japan | Drugs | No Action Indicated (NAI) | 3002808125 |
| Feb 21, 2012 | Oita, Japan | Drugs | Voluntary Action Indicated (VAI) | 3002808279 |
| Aug 25, 2011 | Kurashiki, Japan | Drugs | No Action Indicated (NAI) | 3003973514 |
| Jun 18, 2010 | Anpachi-Gun, Japan | Drugs | Voluntary Action Indicated (VAI) | 3002808125 |
| Jun 5, 2009 | Osaka, Japan | Drugs | No Action Indicated (NAI) | 3002808126 |
| Apr 9, 2009 | Anpachi-Gun, Japan | Drugs | Official Action Indicated (OAI) | 3002808125 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Sumitomo Chemical Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002808125 | Anpachi-Gun, Japan | 7 | Oct 31, 2025 |
| FEI 3002808126 | Osaka, Japan | 3 | Nov 10, 2023 |
| FEI 3003973514 | Kurashiki, Japan | 3 | Nov 2, 2023 |
| FEI 3002808279 | Oita, Japan | 3 | Feb 8, 2019 |
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