Drug factory · FDA FEI 3002807014

Fresenius Kabi Austria GmbH

Estermannstrasse 17, Linz, Austria

Austria: 1

Problems found, fixed voluntarily at FDA's last inspection, May 23, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

6 drug inspections on record since 2011: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AmikacinMakes it, makes the active ingredient and tests it Fresenius Kabi, LLC 63323-815
ClevidipineMakes it and makes the active ingredient Fresenius Kabi Austria GmbH 18124-011
LactuloseMakes it Fresenius Kabi Austria GmbH 18124-002

FDA inspection history

EndedResultProgramProblems noted
May 23, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 15, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 27, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 24, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 7, 2014No problems foundDrug Quality Assurance—
Jul 29, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture; manufacture.