Drug factory · FDA FEI 3007898507
Farmasierra Manufacturing SL
Carretera de Irún Km 26, 200, San Sebastian de los Reyes, Spain
Problems found, fixed voluntarily at FDA's last inspection, Jan 18, 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 2020: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Leucovorin | Makes it, tests it, packages it and labels it | Farmasierra Manufacturing SL | 73591-5886 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 18, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 30, 2020 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.