Drug factory · FDA FEI 3003259844
Sanofi Winthrop Industrie
1051 Boulevard Industriel, Le Trait, France
Problems found, fixed voluntarily at FDA's last inspection, Apr 25, 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 2010: 0 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Alirocumab | Makes it, tests it, packages it and labels it | Regeneron Pharmaceuticals, Inc., Sanofi-Aventis U.S. LLC | 61755-020, 61755-021, 0024-5903 +1 |
| Dupilumab | Makes it, tests it, packages it and labels it | Sanofi-Aventis U.S. LLC | 0024-5914, 0024-5915, 0024-5918 +1 |
| Enoxaparin | Makes it, tests it, packages it and labels it | Fresenius Kabi, LLC, Sanofi-Aventis U.S. LLC | 63323-531, 63323-533, 63323-535 +26 |
| Salmonella Typhi Ty2 Vi Polysaccharide Antigen | Makes it | Sanofi Vaccines US Inc. | 49281-790 |
| Sarilumab | Makes it, tests it, packages it and labels it | Sanofi-Aventis U.S. LLC | 0024-5908, 0024-5910, 0024-5920 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 25, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 7, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 19, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 28, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 28, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 30, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; relabel; repack; sterilize.