Drug factory · FDA FEI 3002807889
Pierre Fabre Medicament
16 rue Jean ROSTAND, Gaillac, France
Problems found, fixed voluntarily at FDA's last inspection, Jul 8, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2013: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Milnacipran | Makes the active ingredient | Glenmark Pharmaceuticals Inc., USA | 68462-763, 68462-764, 68462-765 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 8, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 13, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 15, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 14, 2013 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.