Drug factory · FDA FEI 3008031763
Evonik Operations GmbH
Rodenbacher Chaussee 4, Hanau, Germany
Problems found, fixed voluntarily at FDA's last inspection, Oct 24, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2014: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Pacritinib | Tests it | Sobi, Inc. | 72482-100 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 24, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 13, 2019 | No problems found | Drug Quality Assurance | — |
| Jan 31, 2014 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.