Drug factory · FDA FEI 3006999285
Carbogen Amcis Ag
Neulandweg 5, Hunzenschwil, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Nov 14, 2025.
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 2015: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Brentuximab Vedotin | Tests it | Seagen Inc. | 51144-050 |
| Maribavir | Tests it | Takeda Pharmaceuticals America, Inc. | 64764-800 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 14, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 21, 2024 | No problems found | Drug Quality Assurance | — |
| Oct 22, 2015 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.