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Fresenius Kabi Austria GMBH

FDA Regulatory Profile

Fresenius Kabi Austria GMBH has 0 FDA recalls, 17 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 23, 2025 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections17Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 23, 2025Linz, AustriaDrugsVoluntary Action Indicated (VAI)3002807014
Mar 21, 2024Graz, AustriaDrugsVoluntary Action Indicated (VAI)3003708554
Oct 13, 2022Graz, AustriaDrugsVoluntary Action Indicated (VAI)3003708554
Jul 15, 2021Linz, AustriaDrugsVoluntary Action Indicated (VAI)3002807014
Jan 30, 2020Graz, AustriaDrugsVoluntary Action Indicated (VAI)3003708554
Sep 27, 2018Linz, AustriaDrugsVoluntary Action Indicated (VAI)3002807014
Feb 8, 2018Graz, AustriaDrugsVoluntary Action Indicated (VAI)3003708554
Mar 24, 2017Linz, AustriaDrugsVoluntary Action Indicated (VAI)3002807014
Mar 17, 2017Graz, AustriaDrugsVoluntary Action Indicated (VAI)3003708554
Apr 1, 2016Graz, AustriaDevicesNo Action Indicated (NAI)3003708554
Jun 19, 2015Graz, AustriaDrugsVoluntary Action Indicated (VAI)3003708554
Nov 7, 2014Linz, AustriaDrugsNo Action Indicated (NAI)3002807014
Jul 16, 2013Graz, AustriaDrugsNo Action Indicated (NAI)3003708554
Jul 29, 2011Linz, AustriaDrugsVoluntary Action Indicated (VAI)3002807014
Mar 25, 2011Graz, AustriaDrugsNo Action Indicated (NAI)3003708554
Dec 3, 2009Graz, AustriaDevicesNo Action Indicated (NAI)3003708554
Jul 3, 2009Graz, AustriaDrugsVoluntary Action Indicated (VAI)3003708554

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3002807014Linz, Austria6May 23, 2025
FEI 3003708554Graz, Austria11Mar 21, 2024

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.