Fresenius Kabi Austria
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
- Hafnerstrasse 36 or am Gewerbepark 6, Graz, Werndorf, Austria 8055, 8402, Austria (AUT)
- Operations here
- analysismanufacturepackrepack
- FDA identifiers
- FEI 3003708554 · DUNS 300206604
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-03-21
- VAIDrug Quality Assurance2022-10-13
- VAIDrug Quality Assurance2020-01-30
- VAIDrug Quality Assurance2018-02-08
- VAIDrug Quality Assurance2017-03-17
- VAIDrug Quality Assurance2015-06-19
- NAIDrug Quality Assurance2013-07-16
- NAIDrug Quality Assurance2011-03-25
- VAIDrug Quality Assurance2009-07-03
Drugs this plant is listed as making
19 distinct drugs across 24 products name this site in their FDA label.
- adalimumabFresenius Kabi USA, LLC
- adalimumab-aacfFresenius Kabi USA, LLC
- AdenosineFresenius Kabi USA, LLC
- ephedrine sulfateFresenius Kabi USA, LLC
- Fish oilFresenius Kabi USA, LLC
- foscarnet sodiumFresenius Kabi USA, LLC
- FulvestrantFresenius Kabi USA, LLC
- IcatibantFresenius Kabi USA, LLC
- Leucovorin calciumFresenius Kabi USA, LLC
- Lidocaine Hydrochloridein shortageFresenius Kabi USA, LLC
- PalonosetronFresenius Kabi USA, LLC
- pegflilgrastim-fpgkFresenius Kabi USA, LLC
- PropofolFresenius Kabi USA, LLC
- Ropivacaine Hydrochloridein shortageFresenius Kabi USA, LLC
- Succinylcholine ChlorideFresenius Kabi USA LLC
- Tocilizumab-aazgFresenius Kabi USA, LLC
- ustekinumab-aauzFresenius Kabi USA, LLC
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.