Fresenius Kabi Austria GmbH
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
- Austria
- Registered address
- Estermannstrasse 17, Linz, / 4020, Austria (AUT)
- Operations here
- analysisapi manufacturemanufacture
- FDA identifiers
- FEI 3002807014 · DUNS 303448575
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-05-23
- VAIDrug Quality Assurance2021-07-15
- VAIDrug Quality Assurance2017-03-24
- NAIDrug Quality Assurance2014-11-07
- VAIDrug Quality Assurance2011-07-29
Drugs this plant is listed as making
3 distinct drugs across 3 products name this site in their FDA label.
- Amikacin SulfateFresenius Kabi USA, LLC
- clevidipineFresenius Kabi Austria GmbH
- LactuloseFresenius Kabi Austria GmbH
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.