Drug factory · FDA FEI 3002807817
Fermion Oy
Orioninkatu 2, Hanko Pohjoinen, Finland
Problems found, fixed voluntarily at FDA's last inspection, Mar 14, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2011: 0 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Darolutamide | Makes the active ingredient and tests it | Bayer HealthCare Pharmaceuticals Inc. | 50419-395 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 14, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 17, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 14, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 10, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 14, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 16, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label.