Drug factory · FDA FEI 3002808098
Catalent Germany Eberbach GmbH
Gammelsbacher Strasse 2, Eberbach, Germany
Problems found, fixed voluntarily at FDA's last inspection, Feb 2, 2024.
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: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Elinzanetant | Makes it and tests it | Bayer HealthCare Pharmaceuticals Inc. | 50419-475 |
| Metyrapone | Makes it and tests it | Esteve Pharmaceuticals, S.a., HRA Pharma Rare Diseases | 68118-455, 76336-455 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 2, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 6, 2019 | No problems found | Drug Quality Assurance | — |
| Mar 2, 2018 | No problems found | Drug Quality Assurance | — |
| Mar 18, 2016 | No problems found | Drug Quality Assurance | — |
| Sep 12, 2013 | No problems found | Drug Quality Assurance | — |
| Mar 5, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture.