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Manufacturing facility

Antibiotice SA

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
Romania
Registered address
1 Valea Lupului Street, Iasi, Iasi 707410, Romania (ROU)
Operations here
analysisapi manufacturemanufacture
FDA identifiers
FEI 3003489017 · DUNS 644984809

FDA inspection history

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

  • VAIDrug Quality Assurance2025-09-19
  • VAIDrug Quality Assurance2022-10-14
  • VAIDrug Quality Assurance2019-10-11
  • VAIDrug Quality Assurance2017-03-14
  • NAIDrug Quality Assurance2013-01-22
  • VAIDrug Quality Assurance2010-11-09

Drugs this plant is listed as making

1 distinct drugs across 4 products name this site in their FDA label.

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.