Drug factory · FDA FEI 3009736169
Laboratorios Grifols, S.A.
Paseo Fluvial (pol. Industrial Autopista) 24, Parets del Valles, Spain
Problems found, fixed voluntarily at FDA's last inspection, Oct 27, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
10 drug inspections on record since 2012: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Anhydrous Citric Acid | Makes it, packages it and labels it | Laboratorios Grifols Sa | 76297-006 |
| Chloride Ion | Makes it, packages it and labels it | Laboratorios Grifols Sa | 76297-001 |
| Tirofiban | Makes it, packages it and labels it | Medicure International Inc | 25208-001, 25208-002, 25208-901 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 27, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 27, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 20, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 20, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 8, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 8, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 21, 2015 | No problems found | Drug Quality Assurance | — |
| May 21, 2015 | No problems found | Drug Quality Assurance | — |
| Jul 11, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 11, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: label; manufacture; pack.