Drug factory · FDA FEI 3002996872
Curia Spain Sau
LUGAR PARQUE TECNOLOGICO DE BOECILLO PARC 105, Boecillo, Spain
Problems found, fixed voluntarily at FDA's last inspection, Feb 27, 2023.
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 2008: 4 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Clascoterone | Makes the active ingredient | Caraco Pharmaceutical Laboratories, Ltd. | 47335-994 |
| Paliperidone | Makes the active ingredient, tests it and mills it | Shandong Luye Pharmaceutical Co., Ltd. | 72526-105, 72526-106, 72526-107 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 27, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 12, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 28, 2018 | No problems found | Drug Quality Assurance | — |
| Oct 21, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 21, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 23, 2011 | No problems found | Drug Quality Assurance | — |
| Jun 17, 2011 | No problems found | Drug Quality Assurance | — |
| Oct 27, 2008 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; particle size reduction.