Drug factory · FDA FEI 3003973260
Wyeth Farma SA
Autovia del Norte A-1, KM 23, Desvio Algete KM 1, San Sebastian de los Reyes, Spain
Problems found, fixed voluntarily at FDA's last inspection, Sep 27, 2019.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2014: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Coagulation Factor Ix Recombinant Human and Isopropyl Alcohol | Makes it, tests it, packages it and labels it | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 58394-633, 58394-634, 58394-635 +2 |
| Isopropyl Alcohol and Moroctocog Alfa | Makes it, tests it, packages it and labels it | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 58394-012, 58394-013, 58394-014 +6 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 27, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 18, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 4, 2014 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.