Drug factory · FDA FEI 3010164079
Laboratorios Rubio SA
Calle Industria ((PG Industrial Comte Sert)) 29, Castellbisbal, Spain
Problems found, fixed voluntarily at FDA's last inspection, Sep 22, 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 2017: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cholestyramine | Makes it | Precision Dose Inc., TAGI Pharma, Inc. | 68094-806, 68094-906, 51224-009 +1 |
| Fosfomycin | Makes it | Precision Dose Inc. | 68094-064 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 22, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 31, 2019 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Jun 18, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 30, 2017 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: manufacture.