Drug factory · FDA FEI 3014360923
Universal Farma SL
Calle el Tejido 2, Azuqueca de Henares, Guadalajara, Spain
Problems found, fixed voluntarily at FDA's last inspection, Jun 27, 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 |
|---|---|---|---|
| Bevacizumab | Makes it, tests it and sterilizes it | Amneal Pharmaceuticals LLC | 70121-1754, 70121-1755 |
| Bevacizumab-Maly | Makes it, tests it and sterilizes it | Valorum Biologics LLC | 85006-1754, 85006-1755 |
| Glycopyrronium | Makes it, tests it and sterilizes it | Xiromed, LLC. | 70700-264 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 27, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 3, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture; sterilize.