Drug factory · FDA FEI 3004908885
SGS Institut Fresenius GmbH
Tegeler Weg 33, Berlin, Germany
No problems found at FDA's last inspection, Nov 23, 2023.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2010: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Deferoxamine | Tests it | Mitem Pharma | 87081-467 |
| Ferric Ferrocyanide | Tests it | Heyl Chem.-pharm. Fabrik GmbH & Co. KG | 58060-002 |
| Selexipag | Tests it | Actelion Pharmaceuticals US, Inc. | 66215-602, 66215-604, 66215-606 +8 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 23, 2023 | No problems found | Drug Quality Assurance | — |
| Jun 17, 2019 | No problems found | Drug Quality Assurance | — |
| Jan 27, 2017 | No problems found | Drug Quality Assurance | — |
| May 9, 2014 | No problems found | Drug Quality Assurance | — |
| Apr 27, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 19, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis.