Drug factory · FDA FEI 3002806503
Baxalta Belgium Manufacturing SA
Boulevard René Branquart 80, Lessines, Belgium
Problems found, fixed voluntarily at FDA's last inspection, Jun 18, 2013.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2013: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| .alpha.1-Proteinase Inhibitor Human | Makes it, makes the active ingredient, tests it, packages it and labels it | Takeda Pharmaceuticals America, Inc. | 0944-2884 |
| Antihemophilic Factor, Human Recombinant | Tests it, packages it and labels it | Takeda Pharmaceuticals America, Inc. | 0944-4622, 0944-4623, 0944-4624 +4 |
| Human Immunoglobulin G | Makes it, makes the active ingredient, tests it, packages it and labels it | Takeda Pharmaceuticals America, Inc. | 0944-2700, 0944-2705, 0944-2850 |
| Human Immunoglobulin G and Hyaluronidase (human Recombinant) | Makes it, tests it and packages it | Takeda Pharmaceuticals America, Inc. | 0944-2510, 0944-2511, 0944-2512 +2 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 18, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.