Drug factory · FDA FEI 3002807550
Eurofins Biopharma Product Testing Ireland Limited
Clogherane, Dungarvan, Ireland
Problems found, fixed voluntarily at FDA's last inspection, May 26, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Alglucosidase Alfa | Tests it | Genzyme Corporation | 58468-0160 |
| Alirocumab | Tests it | Regeneron Pharmaceuticals, Inc. | 61755-020, 61755-021 |
| Avalglucosidase Alfa | Tests it | Genzyme Corporation | 58468-0426 |
| Cx-055611 | Tests it | Moderna US, Inc. | 80777-114, 80777-115 |
| Cytarabine and Daunorubicin | Tests it | Jazz Pharmaceuticals, Inc. | 68727-745 |
| Eftrenonacog Alfa | Tests it | Bioverativ Therapeutics Inc. | 71104-911, 71104-922, 71104-933 +3 |
| Imiglucerase | Tests it | Genzyme Corporation | 58468-4663 |
| Isatuximab | Tests it | Sanofi-Aventis U.S. LLC | 0024-0674 |
| Ixazomib | Tests it | Takeda Pharmaceuticals America, Inc. | 63020-230, 63020-390, 63020-400 |
| Olipudase Alfa | Tests it | Genzyme Corporation | 58468-0050, 58468-0051 |
| Sevelamer | Tests it | Genzyme Corporation, Sanofi-Aventis U.S. LLC | 58468-0130, 58468-0131, 58468-0132 +4 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 26, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 17, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 24, 2017 | No problems found | Drug Quality Assurance | — |
| Mar 29, 2013 | No problems found | Drug Quality Assurance | — |
| Sep 30, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.