Drug factory · FDA FEI 3003743938
Orion Corporation, Orion Pharma
Tengstrominkatu 8, Turku, Finland
Problems found, fixed voluntarily at FDA's last inspection, Apr 25, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2009: 3 with no problems, 5 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 |
| Methotrexate | Makes it | Caraco Pharmaceutical Laboratories, Ltd. | 47335-235 |
| Toremifene | Makes it, tests it and packages it | ProStrakan, Inc. | 42747-327 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 25, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 10, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 6, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 3, 2016 | No problems found | Drug Quality Assurance | — |
| Jun 19, 2014 | No problems found | Drug Quality Assurance | — |
| May 24, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 3, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 16, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.