Drug factory · FDA FEI 3007255826
BSP Pharmaceuticals SpA
Via Appia Km 65, 561, Latina Scalo (LT), Italy
Problems found, fixed voluntarily at FDA's last inspection, Nov 12, 2021.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2010: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Eribulin | Makes it and tests it | BSP Pharmaceuticals SpA, Eisai Inc. | 43624-002, 62856-389 |
| Gemcitabine | Makes it and tests it | Janssen Biotech, Inc. | 57894-225 |
| Thiotepa | Makes it and tests it | Amneal Pharmaceuticals LLC | 70121-1630, 70121-1631 |
| Valrubicin | Makes it | ENDO USA, Inc. | 67979-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 12, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 20, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 16, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 26, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Dec 5, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 12, 2010 | 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.
Jun 26, 2015 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures and laboratory control mechanisms are not followed.
Registered with FDA for: analysis; api manufacture; manufacture.