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
Matched to FDA's records by company name, because this plant's registration on the label has expired.
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 |
|---|---|---|---|
| Lamotrigine | Makes it | TruPharma LLC. | 52817-240, 52817-241, 52817-242 +1 |
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.