Drug factory · FDA FEI 3016431308
OFI Technologie & Innovation GmbH
Franz-Grill-Strasse 5, Objekt 213, Vienna, Austria
Problems found, fixed voluntarily at FDA's last inspection, Oct 3, 2018.
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 2018: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| 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 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 3, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis.