Drug factory · FDA FEI 3008915297
Ablynx
Technologiepark-Zwijnaarde 21 Gent, , Zwijnaarde, Belgium
Problems found, fixed voluntarily at FDA's last inspection, May 24, 2024.
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 2021: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Caplacizumab | Tests it | Genzyme Corporation | 58468-0225 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 24, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 9, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture.