Sanofi
Sanofi has 0 FDA recalls, 12 inspections, 2 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Dec 13, 2024 · VAI
- Latest 510(k)
- May 26, 2017
Newer recall under related name Chattem: Mar 26, 2025, D-0362-2025.
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 2 | Oct 4, 2026 | Not stated | Current |
| Inspections | 12 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|---|---|---|---|---|
| Genzyme | 0 | 27 | 1 | 0 | — |
| Chattem | 2 | 1 | 27 | 1 | Mar 26, 2025 (D-0362-2025) |
| Sanofi Genzyme | 1 | 0 | 0 | 0 | Dec 11, 2017 (Z-0607-2018) |
| Genzyme Corporation | 6 | 6 | 26 | 1 | Oct 12, 2017 (D-0075-2018) |
| Sanofi Winthrop Industrie | 0 | 0 | 57 | 1 | — |
| Chattem Chemicals | 0 | 0 | 6 | 0 | — |
| Sanofi Aventis Singapore Pte | 0 | 0 | 6 | 0 | — |
| Genzyme Biosurgery | 0 | 4 | 0 | 0 | — |
| Genzyme Polyclonals | 0 | 0 | 2 | 0 | — |
| Sanofi Aventis Recherche And Developpement | 0 | 0 | 1 | 0 | — |
| Sanofi Chimie | 0 | 0 | 1 | 0 | — |
| Sanofi Us Services | 0 | 0 | 1 | 0 | — |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 13, 2024 | Scoppito, Italy | Drugs | Voluntary Action Indicated (VAI) | 3006947840 |
| Oct 29, 2024 | Anagni, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807108 |
| Jun 21, 2024 | Anagni, Italy | Biologics | No Action Indicated (NAI) | 3002807108 |
| May 20, 2022 | Scoppito, Italy | Drugs | Voluntary Action Indicated (VAI) | 3006947840 |
| Nov 18, 2021 | Anagni, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807108 |
| Jul 18, 2019 | Taylor, PA | Biologics | No Action Indicated (NAI) | 3006855451 |
| Feb 15, 2019 | Anagni, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807108 |
| May 31, 2018 | Anagni, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807108 |
| Jul 29, 2016 | Anagni, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807108 |
| Sep 26, 2014 | Anagni, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807108 |
| Mar 22, 2012 | Anagni, Italy | Drugs | Voluntary Action Indicated (VAI) | 3002807108 |
| Jun 23, 2011 | Anagni, Italy | Devices | Voluntary Action Indicated (VAI) | 3002807108 |