Drug factory · FDA FEI 1000476619
Sanofi Winthrop Industrie
45 Chemin de Meteline, Sisteron, France
Problems found, fixed voluntarily at FDA's last inspection, Sep 15, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2009: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Clopidogrel | Makes the active ingredient and tests it | Sanofi-Aventis U.S. LLC | 0024-1171, 0024-1332 |
| Dronedarone | Makes the active ingredient and tests it | Sanofi-Aventis U.S. LLC | 0024-4142 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 15, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 22, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 29, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 12, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 5, 2012 | No problems found | Drug Quality Assurance | — |
| Jul 17, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.