Drug factory · FDA FEI 3002806657
Solvias France
RUE DU CANAL D ALSACE ZONE INDUSTRIELLE, Hombourg, France
Problems found, fixed voluntarily at FDA's last inspection, Sep 23, 2022.
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 2014: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Selexipag | Tests it | Actelion Pharmaceuticals US, Inc. | 66215-718 |
| Vestronidase Alfa | Tests it | Ultragenyx Pharmaceutical Inc. | 69794-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 23, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 28, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 27, 2014 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.