Drug factory · FDA FEI 3004362706
Allpack Group AG
Pfeffingerstrasse 45, Reinach, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Apr 28, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2011: 5 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bosentan | Packages it and labels it | Actelion Pharmaceuticals US, Inc. | 66215-101, 66215-102, 66215-232 |
| Macitentan | Packages it and labels it | Actelion Pharmaceuticals US, Inc. | 66215-501 |
| Sonrotoclax | Packages it and labels it | BeOne Medicines USA, Inc. | 72579-015, 72579-017, 72579-020 +2 |
| Vamorolone | Makes it | Catalyst Pharmaceuticals, Inc. | 69616-264 |
| Zanubrutinib | Packages it and labels it | BeOne Medicines USA, Inc. | 72579-122 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 28, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 7, 2017 | No problems found | Drug Quality Assurance | — |
| Feb 13, 2015 | No problems found | Drug Quality Assurance | — |
| Feb 22, 2013 | No problems found | Drug Quality Assurance | — |
| Dec 12, 2012 | No problems found | Drug Quality Assurance | — |
| Nov 21, 2011 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: label; manufacture; pack; relabel; repack.