Drug factory · FDA FEI 3005403232
Avyxa GmbH
Via Cadepiano 24, Barbengo, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Oct 3, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2014: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| 4-Hydroxycyclophosphamide | Makes it, tests it, packages it and sterilizes it | BluePoint Laboratories. | 68001-563, 68001-564, 68001-565 |
| Decitabine | Makes it, tests it, packages it, labels it and sterilizes it | Ingenus Pharmaceuticals, LLC | 50742-430 |
| Gemcitabine | Makes it, tests it, packages it, labels it and sterilizes it | Avyxa Pharma, LLC | 83831-122, 83831-123, 83831-124 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 3, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 3, 2019 | No problems found | Drug Quality Assurance | — |
| Oct 31, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 4, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; sterilize.