Drug factory · FDA FEI 1463
Euroapi France
4 La Paterie, Vertolaye, France
No problems found at FDA's last inspection, Mar 8, 2024.
No Action Indicated: inspectors found no objectionable conditions.
8 drug inspections on record since 2008: 4 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Teriflunomide | Makes the active ingredient | Genzyme Corporation | 58468-0210, 58468-0211 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 8, 2024 | No problems found | Drug Quality Assurance | — |
| Feb 11, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 27, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 28, 2019 | No problems found | Drug Quality Assurance | — |
| Nov 17, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 26, 2014 | No problems found | Drug Quality Assurance | — |
| Jun 23, 2011 | No problems found | Drug Quality Assurance | — |
| Oct 30, 2008 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; pack.