Drug factory · FDA FEI 3009883634
Richter Biologics GmbH
Dengelsberg, Bovenau, Germany
Problems found, fixed voluntarily at FDA's last inspection, Jun 30, 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 2019: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Caplacizumab | Makes the active ingredient | Genzyme Corporation | 58468-0225 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 30, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 28, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.