Drug factory · FDA FEI 3002806961
F.i.s. Fabbrica Italiana Sintetici S.p.a.
Viale Milano 26, Montecchio Maggiore, Italy
Problems found, fixed voluntarily at FDA's last inspection, Mar 6, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2009: 4 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Capecitabine | Makes the active ingredient and tests it | H2-Pharma LLC | 61269-470, 61269-475 |
| Dexlansoprazole | Makes the active ingredient and tests it | TWi Pharmaceuticals, Inc. | 24979-703, 24979-704 |
| Elexacaftor and Ivacaftor and Tezacaftor | Makes the active ingredient and tests it | Vertex Pharmaceuticals Incorporated | 51167-106, 51167-331, 51167-445 +1 |
| Perampanel | Makes the active ingredient | Eisai Inc. | 62856-272, 62856-274, 62856-276 +3 |
| Sofosbuvir | Makes the active ingredient and tests it | Gilead Sciences, Inc. | 61958-1501, 61958-1503, 61958-1504 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 6, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 6, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 6, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 17, 2017 | No problems found | Drug Quality Assurance | — |
| Apr 23, 2015 | No problems found | Drug Quality Assurance | — |
| Mar 29, 2012 | No problems found | Drug Quality Assurance | — |
| Apr 24, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture.