Polaroisin International Co., Ltd. FDA Record
- Latest inspection OAI · Sep 15, 2017
- Last warning letter 2018
Polaroisin International Co., Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Polaroisin International Co., Ltd., the most recent on Jan 26, 2018.
- Latest inspection
- Sep 15, 2017 · OAI
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 | 1 | 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
Polaroisin International Co., Ltd.: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 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 | 1 | 0 | 0 |
| 2017 | 1 | 1 | 0 | 0 | 0 |
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Polaroisin International Co., Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Jan 26, 2018 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 15, 2017 | New Taipei City, Taiwan | Drugs | Official Action Indicated (OAI) | 3008004582 |
- 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 Polaroisin International Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3008004582 | New Taipei City, Taiwan | 1 | Sep 15, 2017 |
Polaroisin International Co., Ltd. and the FDA: common questions
Has Polaroisin International Co., Ltd. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Polaroisin International Co., Ltd.. The most recent is dated Jan 26, 2018.
Has Polaroisin International Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Polaroisin International Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Polaroisin International Co., Ltd.?
The most recent FDA inspection on file ended Sep 15, 2017 at New Taipei City, Taiwan and was classified OAI. FDA has 1 inspection of Polaroisin International Co., Ltd. on file, 1 of them classified OAI (official action indicated).
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