Genzyme Polyclonals S.A.S.
Genzyme Polyclonals S.A.S. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jan 14, 2013 · VAI
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 | 0 | Oct 4, 2026 | Not stated | Current |
| Inspections | 2 | 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 |
|---|---|---|---|---|---|
| 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 | — |
| Sanofi | 0 | 2 | 12 | 0 | — |
| Chattem Chemicals | 0 | 0 | 6 | 0 | — |
| Sanofi Aventis Singapore Pte | 0 | 0 | 6 | 0 | — |
| Genzyme Biosurgery | 0 | 4 | 0 | 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 |
|---|---|---|---|---|
| Jan 14, 2013 | Marcy L Etoile, France | Biologics | Voluntary Action Indicated (VAI) | 3002650449 |
| Oct 6, 2010 | Marcy L Etoile, France | Biologics | Voluntary Action Indicated (VAI) | 3002650449 |