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Manufacturing facility

Alfasigma Spa

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
Via Pontina Km 30,400, Pomezia, Rome 00071, Italy (ITA)
Operations here
manufacture
FDA identifiers
FEI 3002808171 · DUNS 438538098

FDA inspection history

Outcomes of closed FDA inspections at this site (drug and biologic program areas).

  • VAIDrug Quality Assurance2024-01-26
  • VAIDrug Quality Assurance2021-05-28
  • VAIDrug Quality Assurance2018-06-21
  • VAIDrug Quality Assurance2015-11-10
  • VAIDrug Quality Assurance2011-09-16

Drugs this plant is listed as making

0 distinct drugs across 0 products name this site in their FDA label.

No drug labels currently list this site.

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.