Drug factory · FDA FEI 3002807552
Medichem SA
Poligono Industrial de Celra, Celra, Spain
Problems found, fixed voluntarily at FDA's last inspection, Jun 22, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cyclobenzaprine | Makes the active ingredient | Amneal Pharmaceuticals | 0115-1436, 0115-1437 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 22, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 15, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 30, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 21, 2012 | No problems found | Drug Quality Assurance | — |
| Apr 9, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.