Drug factory · FDA FEI 3002808332
Evonik Operations GmbH
Gutenbergstrasse 2, Dossenheim, Germany
No problems found at FDA's last inspection, Sep 15, 2023.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2009: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide | Makes the active ingredient | Janssen Products LP | 59676-800 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 15, 2023 | No problems found | Drug Quality Assurance | — |
| Sep 29, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 21, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 1, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.