Drug factory · FDA FEI 3002807470
Novartis d.o.o.
Kolodvorska cesta 27, Menges, Slovenia
No problems found at FDA's last inspection, Sep 21, 2022.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2009: 5 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tislelizumab | Makes the active ingredient and tests it | BeOne Medicines USA, Inc. | 72579-121, 72579-125 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 21, 2022 | No problems found | Drug Quality Assurance | — |
| Sep 11, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 13, 2017 | No problems found | Drug Quality Assurance | — |
| Sep 18, 2015 | No problems found | Drug Quality Assurance | — |
| Oct 19, 2012 | No problems found | Drug Quality Assurance | — |
| Aug 12, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture.