Drug factory · FDA FEI 3007048260
Italfarmaco S.A.
CALLE DE SAN RAFAEL (P I ALCOBENDAS) 3, Alcobendas, Spain
Problems found, fixed voluntarily at FDA's last inspection, Jul 15, 2021.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2021: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Givinostat | Makes it, tests it, packages it and labels it | Italfarmaco S.p.A | 11797-110 |
| Riluzole | Makes it, tests it and packages it | Italfarmaco S.p.A | 11797-210 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 15, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.