Drug factory · FDA FEI 3002808450
Vifor (International) Inc.
Rechenstrasse 37, St. Gallen, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Sep 6, 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 2010: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ferric Cation | Makes it and makes the active ingredient | American Regent, Inc., Fresenius Medical Care Holdings, Inc., Sandoz Inc. | 0517-0602, 0517-0620, 0517-0650 +6 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 6, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 22, 2016 | No problems found | Drug Quality Assurance | — |
| Nov 15, 2012 | No problems found | Drug Quality Assurance | — |
| Apr 15, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture.