Drug factory · FDA FEI 3010418451
Tjoapack Netherlands BV
Nieuwe Donk 9, Etten-Leur, Netherlands
Problems found, fixed voluntarily at FDA's last inspection, Feb 13, 2025.
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 2022: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Mecasermin | Packages it and labels it | Eton Pharmaceuticals, Inc., Ipsen Biopharmaceuticals, Inc. | 71863-216, 15054-1040 |
| Tildrakizumab | Packages it | Caraco Pharmaceutical Laboratories, Ltd. | 47335-177 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 13, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 14, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: label; pack; repack.