Sinsin Pharmaceutical Co., Ltd.
Sinsin Pharmaceutical Co., Ltd. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest inspection
- Feb 14, 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 | 5 | 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 | 1 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 14, 2025 | Sejong, Korea (The Republic Of) | Drugs | Voluntary Action Indicated (VAI) | 3002277609 |
| Dec 13, 2019 | Sejong, Korea (The Republic Of) | Drugs | Voluntary Action Indicated (VAI) | 3002277609 |
| Nov 24, 2017 | Sejong, Korea (The Republic Of) | Drugs | Voluntary Action Indicated (VAI) | 3002277609 |
| Mar 11, 2016 | Sejong, Korea (The Republic Of) | Drugs | Voluntary Action Indicated (VAI) | 3002277609 |
| Mar 2, 2012 | Sejong, Korea (The Republic Of) | Drugs | Voluntary Action Indicated (VAI) | 3002277609 |
- 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 Sinsin Pharmaceutical Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002277609 | Sejong, Korea (The Republic Of) | 5 | Feb 14, 2025 |
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