SunPolar International Co., Ltd FDA Record
SunPolar International Co., Ltd has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "SunPolar International Co., Ltd" is on file.
- Latest inspection
- Mar 27, 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 | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 27, 2025 | Changhua County, Taiwan | Devices | Voluntary Action Indicated (VAI) | 3008381219 |
| Dec 17, 2015 | Changhua County, Taiwan | Devices | Voluntary Action Indicated (VAI) | 3008381219 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3008381219 | Changhua County, Taiwan | 2 | Mar 27, 2025 |
SunPolar International Co., Ltd and the FDA: common questions
Has SunPolar International Co., Ltd received an FDA warning letter?
No FDA warning letter addressed to the name "SunPolar International Co., Ltd" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has SunPolar International Co., Ltd received an FDA Form 483?
FDA has not published a Form 483 for "SunPolar International Co., Ltd" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect SunPolar International Co., Ltd?
The most recent FDA inspection on file ended Mar 27, 2025 at Changhua County, Taiwan and was classified VAI. FDA has 2 inspections of SunPolar International Co., Ltd on file.
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