Drug factory · FDA FEI 3002808431
Union Quimico Farmaceutica Sa
P.I.Moli De Les Planes Font De Bocs, S/N (C-35 KM 57), , Sant Celoni, Spain
Problems found, fixed voluntarily at FDA's last inspection, Jul 7, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2009: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide | Makes the active ingredient | Janssen Products LP | 59676-800 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 7, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 7, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 1, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 1, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 15, 2015 | No problems found | Drug Quality Assurance | — |
| May 15, 2015 | No problems found | Drug Quality Assurance | — |
| Jun 18, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 18, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.