Drug factory · FDA FEI 3003706029
Eurofins Biopharma Product Testing Munich GmbH
Robert-Koch-Strasse 3a, Planegg, Germany
Problems found, fixed voluntarily at FDA's last inspection, Jun 23, 2023.
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 |
|---|---|---|---|
| Aflibercept | Tests it | Regeneron Pharmaceuticals, Inc. | 61755-005 |
| Alirocumab | Tests it | Regeneron Pharmaceuticals, Inc. | 61755-020, 61755-021 |
| Eftrenonacog Alfa | Tests it | Bioverativ Therapeutics Inc. | 71104-911, 71104-922, 71104-933 +3 |
| Sutimlimab | Tests it | Bioverativ Therapeutics Inc. | 80203-347 |
| Tocilizumab | Tests it | Biogen MA Inc. | 64406-022, 64406-023 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 23, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 12, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 12, 2014 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 12, 2019 inspection
- Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Registered with FDA for: analysis.