Sm Eng Co., Ltd. FDA Record
- Latest inspection VAI · Jul 21, 2023
- No warning letters matched by name
Sm Eng Co., Ltd. has 0 FDA recalls, 1 inspection, 5 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sm Eng Co., Ltd." is on file.
- Latest inspection
- Jul 21, 2023 · VAI
- Latest 510(k)
- Jul 7, 2020
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 5 | Nov 8, 2026 | File dated Nov 2, 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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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 21, 2023 | Sasang, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3008912461 |
- 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 3008912461 | Sasang, Korea (The Republic Of) | 1 | Jul 21, 2023 |
Sm Eng Co., Ltd. and the FDA: common questions
Has Sm Eng Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Sm Eng 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 Sm Eng Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Sm Eng Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Sm Eng Co., Ltd.?
The most recent FDA inspection on file ended Jul 21, 2023 at Sasang, Korea (The Republic Of) and was classified VAI. FDA has 1 inspection of Sm Eng Co., Ltd. on file.
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