Sportarredo Group S.C. FDA Record
- Latest inspection VAI · Dec 19, 2024
- No warning letters matched by name
Sportarredo Group S.C. has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sportarredo Group S.C." is on file.
- Latest inspection
- Dec 19, 2024 · VAI
- Latest 510(k)
- Jul 6, 2017
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 | 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 |
|---|---|---|---|---|
| Dec 19, 2024 | Gruaro, Italy | Devices | Voluntary Action Indicated (VAI) | 3001048992 |
| Jul 22, 2016 | Gruaro, Italy | Devices | Voluntary Action Indicated (VAI) | 3001048992 |
- 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 3001048992 | Gruaro, Italy | 2 | Dec 19, 2024 |
Sportarredo Group S.C. and the FDA: common questions
Has Sportarredo Group S.C. received an FDA warning letter?
No FDA warning letter addressed to the name "Sportarredo Group S.C." 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 Sportarredo Group S.C. received an FDA Form 483?
FDA has not published a Form 483 for "Sportarredo Group S.C." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Sportarredo Group S.C.?
The most recent FDA inspection on file ended Dec 19, 2024 at Gruaro, Italy and was classified VAI. FDA has 2 inspections of Sportarredo Group S.C. on file.
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