Drug factory · FDA FEI 3001670824
AndersonBrecon (UK) Limited
Pharos House, Wye Valley Business Park, Brecon Road, , Hay-on-Wye, Hereford, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Apr 5, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2011: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ixazomib | Packages it and labels it | Takeda Pharmaceuticals America, Inc. | 63020-230, 63020-390, 63020-400 |
| Neratinib | Packages it and labels it | Puma Biotechnology, Inc. | 70437-240 |
| Solriamfetol | Packages it and labels it | Axsome Therapeutics, Inc. | 81968-350, 81968-351 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 5, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 27, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 18, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 13, 2015 | No problems found | Drug Quality Assurance | — |
| Feb 24, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; relabel.