Guedant Sas FDA Record
Guedant Sas has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Guedant Sas" is on file.
- Latest inspection
- Apr 4, 2025 · NAI
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 4, 2025 | Poigny, France | Food/Cosmetics | No Action Indicated (NAI) | 3011479684 |
- 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 3011479684 | Poigny, France | 1 | Apr 4, 2025 |
Guedant Sas and the FDA: common questions
Has Guedant Sas received an FDA warning letter?
No FDA warning letter addressed to the name "Guedant Sas" 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 Guedant Sas received an FDA Form 483?
FDA has not published a Form 483 for "Guedant Sas" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Guedant Sas?
The most recent FDA inspection on file ended Apr 4, 2025 at Poigny, France and was classified NAI. FDA has 1 inspection of Guedant Sas on file.
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