Drug factory · FDA FEI 3002806530
Eurofins Biolab Srl
Via Bruno Buozzi 2, Vimodrone, Italy
Problems found, fixed voluntarily at FDA's last inspection, Sep 13, 2024.
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: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dantrolene | Tests it | Uswm, LLC | 78670-003 |
| Daratumumab | Tests it | Janssen Biotech, Inc. | 57894-505 |
| Doxorubicin | Tests it | Baxter Healthcare Corporation | 0338-9665, 0338-9667 |
| Gemcitabine | Tests it | Janssen Biotech, Inc. | 57894-225 |
| Minocycline | Tests it | Melinta Therapeutics, LLC | 70842-160 |
| Nipocalimab | Tests it | Janssen Biotech, Inc. | 57894-800, 57894-801 |
| Omidubicel and Omidubicel Non-Cultured Fraction | Tests it | Gamida Cell Inc. | 73441-800 |
| Talazoparib | Tests it | Pfizer Laboratories Div Pfizer Inc | 0069-0252, 0069-0353, 0069-0454 +3 |
| Thiotepa | Tests it | Amneal Pharmaceuticals LLC | 70121-1630, 70121-1631, 70121-1687 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 13, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 5, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 18, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| May 21, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 20, 2009 | 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.
Apr 18, 2018 inspection
- Identification of Components and In-Process Materials 21 CFR 211.188(b)(3)
The batch production and control records are deficient in that they do not include specific identification of each batch of component and in-process material used. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up. - Testing Calculations 21 CFR 211.194(a)(5)
Laboratory records are deficient in that they do not include all calculations performed during testing.
Registered with FDA for: analysis.