Unilam Co., Ltd. FDA Record
- Latest inspection VAI · Dec 8, 2022
- Last warning letter 2026
Unilam Co., Ltd. has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record. FDA has issued 1 warning letter to Unilam Co., Ltd., the most recent on Sep 22, 2026.
- Latest inspection
- Dec 8, 2022 · VAI
- Latest 510(k)
- Feb 15, 2023
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 2 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Unilam Co., Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Sep 22, 2026 · Letter on fda.gov | CGMP/QSR/Medical Devices/Adulterated | Center for Devices and Radiological Health |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 8, 2022 | Ulju, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3007123863 |
- 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 3007123863 | Ulju, Korea (The Republic Of) | 1 | Dec 8, 2022 |
Unilam Co., Ltd. and the FDA: common questions
Has Unilam Co., Ltd. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Unilam Co., Ltd.. The most recent is dated Sep 22, 2026, with the subject "CGMP/QSR/Medical Devices/Adulterated".
Has Unilam Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Unilam Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Unilam Co., Ltd.?
The most recent FDA inspection on file ended Dec 8, 2022 at Ulju, Korea (The Republic Of) and was classified VAI. FDA has 1 inspection of Unilam Co., Ltd. on file.
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