SMEG S.P.A. FDA Record
- Latest inspection VAI · May 11, 2023
- No warning letters matched by name
SMEG S.P.A. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "SMEG S.P.A." is on file.
- Latest inspection
- May 11, 2023 · 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 | 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 |
|---|---|---|---|---|
| May 11, 2023 | Guastalla, Italy | Devices | Voluntary Action Indicated (VAI) | 1000274819 |
- 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 1000274819 | Guastalla, Italy | 1 | May 11, 2023 |
SMEG S.P.A. and the FDA: common questions
Has SMEG S.P.A. received an FDA warning letter?
No FDA warning letter addressed to the name "SMEG S.P.A." 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 SMEG S.P.A. received an FDA Form 483?
FDA has not published a Form 483 for "SMEG S.P.A." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect SMEG S.P.A.?
The most recent FDA inspection on file ended May 11, 2023 at Guastalla, Italy and was classified VAI. FDA has 1 inspection of SMEG S.P.A. on file.
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