Drug factory · FDA FEI 3011445650
BioConnection B.V.
Kloosterstraat 9 RY, Oss, Netherlands
Problems found, fixed voluntarily at FDA's last inspection, Jan 10, 2025.
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 2025: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Motixafortide | Makes it | BioLineRx USA Inc, Gamida Cell Inc. | 82737-073, 73441-062 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 10, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: manufacture.