Organ Eco Tech FDA Record
- Latest inspection VAI · Apr 11, 2013
- No warning letters matched by name
Organ Eco Tech has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Organ Eco Tech" is on file.
- Latest inspection
- Apr 11, 2013 · 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 | 1 | 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 |
|---|---|---|---|---|
| Apr 11, 2013 | Seongnam, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3008526708 |
- 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 3008526708 | Seongnam, Korea (The Republic Of) | 1 | Apr 11, 2013 |
Organ Eco Tech and the FDA: common questions
Has Organ Eco Tech received an FDA warning letter?
No FDA warning letter addressed to the name "Organ Eco Tech" 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 Organ Eco Tech received an FDA Form 483?
FDA has not published a Form 483 for "Organ Eco Tech" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Organ Eco Tech?
The most recent FDA inspection on file ended Apr 11, 2013 at Seongnam, Korea (The Republic Of) and was classified VAI. FDA has 1 inspection of Organ Eco Tech on file.
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