Drug factory · FDA FEI 3007373388
Lab-Service SAS
455 Zone Artisanale du Verdier, La Roche Vineuse, France
Problems found, fixed voluntarily at FDA's last inspection, Mar 7, 2025.
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: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Elafibranor | Mills it | Ipsen Biopharmaceuticals, Inc. | 15054-0080 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 7, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 5, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 17, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 25, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 27, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; particle size reduction.