Drug factory · FDA FEI 3003340711
Fermion Oy
Laaketehtaantie 2, Oulu, Finland
No problems found at FDA's last inspection, Jan 31, 2023.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2010: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Darolutamide | Tests it | Bayer HealthCare Pharmaceuticals Inc. | 50419-395 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 31, 2023 | No problems found | Drug Quality Assurance | — |
| Feb 12, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 8, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 3, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 13, 2013 | No problems found | Drug Quality Assurance | — |
| Sep 29, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label.