Drug factory · FDA FEI 3003046565
Takeda Manufacturing Austria AG
Uferstraße 15, Orth an der Donau, Austria
No problems found at FDA's last inspection, Apr 24, 2024.
No Action Indicated: inspectors found no objectionable conditions.
1 drug inspection on record since 2024: 1 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| .alpha.1-Proteinase Inhibitor Human | Tests it |
Takeda Pharmaceuticals America, Inc. |
0944-2814, 0944-2815, 0944-2884 |
| Antihemophilic Factor, Human Recombinant | Tests it |
Takeda Pharmaceuticals America, Inc. |
0944-4622, 0944-4623, 0944-4624 +4 |
| Apadamtase Alfa | Tests it |
Takeda Pharmaceuticals America, Inc. |
64764-140, 64764-145 |
| Coagulation Factor Ix Recombinant Human | Tests it |
Takeda Pharmaceuticals America, Inc. |
0944-3026, 0944-3028, 0944-3030 +2 |
| Human C1-Esterase Inhibitor | Tests it |
Takeda Pharmaceuticals America, Inc. |
42227-081, 42227-083 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| Apr 24, 2024 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.