Drug factory · FDA FEI 3002996751
Konapharma AG
Im Wannenboden 16, Pratteln, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Jun 19, 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 2009: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ponesimod | Makes it | Janssen Pharmaceuticals, Inc. | 50458-707, 50458-720 |
| Selexipag | Makes it | Actelion Pharmaceuticals US, Inc. | 66215-718 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 19, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 22, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 22, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 17, 2013 | No problems found | Drug Quality Assurance | — |
| Sep 15, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: manufacture.