Drug factory · FDA FEI 3003677892
Euroapi Italy SRL
Via Angelo Titi 22/26, Brindisi, Italy
Serious problems, FDA action at FDA's last inspection, Jul 17, 2026.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
5 drug inspections on record since 2011: 1 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Rifampin | Makes the active ingredient and tests it | Sanofi-Aventis U.S. LLC | 0068-0597, 0068-0599, 0068-0660 |
| Rifapentine | Makes the active ingredient and tests it | sanofi-aventis U.S. LLC | 0088-2102 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 17, 2026 | Serious problems, FDA action | Drug Quality Assurance | — |
| Feb 25, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 9, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 29, 2014 | No problems found | Drug Quality Assurance | — |
| Mar 17, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; pack.