Drug factory · FDA FEI 3003282644
Sanofi Winthrop Industrie
30 AVENUE GUSTAVE EIFFEL, Tours, France
Problems found, fixed voluntarily at FDA's last inspection, Jan 27, 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: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Clopidogrel | Tests it, packages it and labels it | Sanofi-Aventis U.S. LLC | 0024-1171, 0024-1332 |
| Dronedarone | Packages it and labels 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 | Packages it and labels it | Sanofi-Aventis U.S. LLC | 0024-5855, 0024-5856 |
| Irbesartan | Makes it, tests it, packages it and labels it | Sanofi-Aventis U.S. LLC | 0024-5851, 0024-5852 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 27, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 10, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 15, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jun 6, 2014 | No problems found | Drug Quality Assurance | — |
| Mar 23, 2012 | No problems found | Drug Quality Assurance | — |
| Apr 29, 2010 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jun 15, 2018 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Registered with FDA for: analysis; label; manufacture; pack.