F.i.s. Fabbrica Italiana Sintetici S.p.a.
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- Italy
- Registered address
- Viale Milano 26, Montecchio Maggiore, Vicenza 36075, Italy (ITA)
- Operations here
- analysisapi manufacturemanufacture
- FDA identifiers
- FEI 3002806961 · DUNS 431189117
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-05-06
- VAIDrug Quality Assurance2018-07-06
- NAIDrug Quality Assurance2017-02-17
- NAIDrug Quality Assurance2015-04-23
- NAIDrug Quality Assurance2012-03-29
- NAIDrug Quality Assurance2009-04-24
Drugs this plant is listed as making
3 distinct drugs across 11 products name this site in their FDA label.
- capecitabineH2-Pharma, LLC
- perampanelEisai Inc.
- SofosbuvirGilead Sciences, Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.