Asanuma Corporation - Sagamihara Factory FDA Record
- Latest inspection VAI · Feb 28, 2025
- Last warning letter 2026
Asanuma Corporation - Sagamihara Factory has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Asanuma Corporation - Sagamihara Factory, the most recent on Jun 2, 2026.
- Latest inspection
- Feb 28, 2025 · VAI
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 | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Asanuma Corporation - Sagamihara Factory: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 1 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Asanuma Corporation - Sagamihara Factory FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Jun 2, 2026 · Letter on fda.gov | CGMP/OTC Finished Pharmaceuticals/Adulterated | Center for Drug Evaluation and Research (CDER) |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 28, 2025 | Sagamihara, Japan | Drugs | Voluntary Action Indicated (VAI) | 3010960168 |
| Feb 2, 2017 | Sagamihara, Japan | Drugs | Voluntary Action Indicated (VAI) | 3010960168 |
- 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 Asanuma Corporation - Sagamihara Factory: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3010960168 | Sagamihara, Japan | 2 | Feb 28, 2025 |
Asanuma Corporation - Sagamihara Factory and the FDA: common questions
Has Asanuma Corporation - Sagamihara Factory received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Asanuma Corporation - Sagamihara Factory. The most recent is dated Jun 2, 2026, with the subject "CGMP/OTC Finished Pharmaceuticals/Adulterated".
Has Asanuma Corporation - Sagamihara Factory received an FDA Form 483?
FDA has not published a Form 483 for "Asanuma Corporation - Sagamihara Factory" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Asanuma Corporation - Sagamihara Factory?
The most recent FDA inspection on file ended Feb 28, 2025 at Sagamihara, Japan and was classified VAI. FDA has 2 inspections of Asanuma Corporation - Sagamihara Factory on file.
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