Drug factory · FDA FEI 3002808208
Sanofi Winthrop Industrie
1 RUE DE LA VIERGE, Ambares Et Lagrave, France
Problems found, fixed voluntarily at FDA's last inspection, Nov 22, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Clopidogrel | Makes it, tests it, packages it and labels it | Sanofi-Aventis U.S. LLC | 0024-1171, 0024-1332 |
| Dronedarone | Makes it and tests it | Sanofi-Aventis U.S. LLC | 0024-4142 |
| Eliglustat | Makes it, tests it, packages it and labels it | Genzyme Corporation | 58468-0220 |
| Hydrochlorothiazide and Irbesartan | Makes it and tests it | Sanofi-Aventis U.S. LLC | 0024-5855, 0024-5856 |
| Irbesartan | Makes it and tests it | Sanofi-Aventis U.S. LLC | 0024-5851, 0024-5852 |
| Sevelamer | Makes it, tests it, packages it and labels it | Genzyme Corporation | 58468-0130, 58468-0131, 58468-0132 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 22, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 20, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 6, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 4, 2011 | No problems found | Drug Quality Assurance | — |
| Jan 23, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.