Drug factory · FDA FEI 3007007549
Bluepharma - IndÚstria FarmacÊutica, S.a.
RUA ADRIANO LUCAS, Coimbra, Portugal
Problems found, fixed voluntarily at FDA's last inspection, May 9, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
14 drug inspections on record since 2009: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tofacitinib | Makes it, tests it, packages it and labels it | Somerset Therapeutics, LLC | 70069-841, 70069-842 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 9, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 9, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 13, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 13, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 24, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 24, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 28, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 28, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 24, 2014 | No problems found | Drug Quality Assurance | — |
| Jul 24, 2014 | No problems found | Drug Quality Assurance | — |
| Jul 26, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jul 26, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Oct 8, 2009 | No problems found | Drug Quality Assurance | — |
| Oct 8, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 26, 2012 inspection
- Drug product reserve containers 21 CFR 211.170(b)
Drug product reserve samples are not stored in the same immediate container-closure system as the marketed product and an immediate container-closure system that has essentially the same characteristics as the marketed product. - Drug product reserve containers 21 CFR 211.170(b)
Drug product reserve samples are not stored in the same immediate container-closure system as the marketed product and an immediate container-closure system that has essentially the same characteristics as the marketed product.
Registered with FDA for: analysis; label; manufacture; pack.