Drug factory · FDA FEI 3003121577
Towa Pharmaceutical Europe, S.L.
Calle de Sant Marti, 75-97, Martorelles, Spain
Problems found, fixed voluntarily at FDA's last inspection, Sep 9, 2022.
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 2010: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Duloxetine | Makes it | BluePoint Laboratories., Breckenridge Pharmaceutical, Inc., Golden State Medical Supply, Inc., Quallent Pharmaceuticals Health LLC | 68001-368, 51991-746, 51991-747 +9 |
| Omeprazole | Makes it | Golden State Medical Supply, Inc. | 51407-664, 51407-814 |
| Oxcarbazepine | Makes it and tests it | Breckenridge Pharmaceutical, Inc. | 51991-053, 51991-054, 51991-055 +3 |
| Tofacitinib | Makes it | Breckenridge Pharmaceutical, Inc. | 51991-329, 51991-963 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 9, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 18, 2019 | No problems found | Drug Quality Assurance | — |
| Mar 31, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 13, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 10, 2013 | No problems found | Drug Quality Assurance | — |
| Feb 19, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture.