Drug factory · FDA FEI 3006720740
Redox Srl
Via Gian Battista Stucchi 62/26, Monza, Italy
Problems found, fixed voluntarily at FDA's last inspection, Mar 8, 2023.
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 2011: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Minocycline | Tests it | Melinta Therapeutics, LLC | 70842-160 |
| Tisotumab Vedotin | Tests it | Seagen Inc. | 51144-003 |
| Trimipramine | Tests it | Breckenridge Pharmaceutical, Inc. | 51991-944, 51991-945, 51991-946 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 8, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 24, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 20, 2015 | No problems found | Unapproved and Misbranded Drugs | — |
| Feb 20, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 28, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis.