Drug factory · FDA FEI 3002808341
Sanofi Winthrop Industrie
Route D Avignon, Aramon, France
Problems found, fixed voluntarily at FDA's last inspection, Mar 10, 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: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Hydrochlorothiazide and Irbesartan | Makes the active ingredient and tests it | Sanofi-Aventis U.S. LLC | 0024-5855, 0024-5856 |
| Irbesartan | Makes the active ingredient and tests it | Sanofi-Aventis U.S. LLC | 0024-5851, 0024-5852 |
| Rasburicase | Makes the active ingredient and tests it | Sanofi-Aventis U.S. LLC | 0024-5150, 0024-5151 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 10, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 29, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 25, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 25, 2013 | No problems found | Drug Quality Assurance | — |
| Sep 29, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 17, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.