Sewoo Co., Ltd. FDA Record
- Latest inspection VAI · May 26, 2016
- No warning letters matched by name
Sewoo Co., Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sewoo Co., Ltd." is on file.
- Latest inspection
- May 26, 2016 · VAI
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 | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 2 | 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 |
|---|---|---|---|---|
| May 26, 2016 | Siheung, Korea (The Republic Of) | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3004208290 |
| Apr 10, 2012 | Siheung, Korea (The Republic Of) | Food/Cosmetics | No Action Indicated (NAI) | 3004208290 |
- 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 3004208290 | Siheung, Korea (The Republic Of) | 2 | May 26, 2016 |
Sewoo Co., Ltd. and the FDA: common questions
Has Sewoo Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Sewoo 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 Sewoo Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Sewoo Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Sewoo Co., Ltd.?
The most recent FDA inspection on file ended May 26, 2016 at Siheung, Korea (The Republic Of) and was classified VAI. FDA has 2 inspections of Sewoo Co., Ltd. on file.
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