Drug factory · FDA FEI 3005115446
BioSpring Gesellschaft für Biotechnologie mbH
Alt Fechenheim 34, Frankfurt am Main, Germany
Problems found, fixed voluntarily at FDA's last inspection, Nov 15, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2018: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fitusiran | Makes the active ingredient and tests it | Genzyme Corporation | 58468-0347, 58468-0348 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 15, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 16, 2018 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.