Drug factory · FDA FEI 3002808000

Sanofi Winthrop Industrie

9 Quai Jules Guesde, Vitry sur-Seine, France

France: 1

Problems found, fixed voluntarily at FDA's last inspection, Oct 4, 2024.

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

DrugRoleForNDC
AlirocumabMakes the active ingredient and tests it Regeneron Pharmaceuticals, Inc., Sanofi-Aventis U.S. LLC 61755-020, 61755-021, 0024-5901 +3
CabazitaxelMakes the active ingredient and tests it Sanofi-Aventis U.S. LLC 0024-5824
DocetaxelMakes the active ingredient and tests it Sanofi-Aventis U.S. LLC 0955-1020, 0955-1021, 0955-1022
IsatuximabMakes the active ingredient and tests it Sanofi-Aventis U.S. LLC 0024-0654, 0024-0656, 0024-0674

FDA inspection history

EndedResultProgramProblems noted
Oct 4, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
May 12, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 13, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 3, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 7, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 30, 2010Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.