Drug factory · FDA FEI 3003759588
SGS Institut Fresenius GmbH
Im Maisel 14, Taunusstein, Germany
Problems found, fixed voluntarily at FDA's last inspection, Feb 21, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2012: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Capsaicin | Tests it | Averitas Pharma, Inc. | 72512-928, 72512-929, 72512-930 |
| Deferoxamine | Tests it | Mitem Pharma | 87081-467 |
| Macitentan | Tests it | Actelion Pharmaceuticals US, Inc. | 66215-501 |
| Selexipag | Tests it | Actelion Pharmaceuticals US, Inc. | 66215-602, 66215-604, 66215-606 +8 |
| Talazoparib | Tests it | U.S. Pharmaceuticals | 63539-051, 63539-295 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 21, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 18, 2019 | No problems found | Drug Quality Assurance | — |
| Sep 19, 2014 | No problems found | Drug Quality Assurance | — |
| Sep 26, 2012 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.