Drug factory · FDA FEI 3006947840
Sanofi S.r.l.
Strada Statale 17 Km 22, Scoppito, Italy
Problems found, fixed voluntarily at FDA's last inspection, Dec 13, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2022: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Belumosudil | Makes it, tests it, packages it and labels it | Kadmon Pharmaceuticals, LLC | 79802-200 |
| Rilzabrutinib | Makes it, tests it, packages it and labels it | Genzyme Corporation | 58468-0251 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 13, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 20, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.