Drug factory · FDA FEI 3014424887
Laboratorios Farmalan, S.A.
CALLE LA VALLINA (POL. IND. NAVATEJERA), S/N - EDIF. 2, Villaquilambre, Spain
Problems found, fixed voluntarily at FDA's last inspection, Oct 17, 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 2021: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carboprost | Makes it, tests it and sterilizes it | Somerset Therapeutics, LLC | 70069-825 |
| Estradiol | Makes it, tests it and sterilizes it | Xiromed, LLC. | 70700-273, 70700-274, 70700-275 |
| Fulvestrant | Makes it and tests it | Northstar Rx LLC., Xiromed, LLC. | 16714-070, 70700-284 |
| Medroxyprogesterone | Makes it, tests it and sterilizes it | Amneal Pharmaceuticals LLC | 70121-1467, 70121-1480 |
| Progesterone | Makes it | Xiromed, LLC. | 70700-286 |
| Testosterone | Makes it | Xiromed, LLC. | 70700-288, 70700-289, 70700-290 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 17, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 17, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture; sterilize.