Drug factory · FDA FEI 3002806523

Sandoz GmbH

Biochemiestrasse 10, Kundl, Austria

Austria: 1

Problems found, fixed voluntarily at FDA's last inspection, Nov 17, 2023.

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

9 drug inspections on record since 2009: 1 with no problems, 8 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Amoxicillin and Clarithromycin and VonoprazanMakes it, makes the active ingredient, tests it and packages it Phathom Pharmaceuticals Inc. 81520-255
Amoxicillin and VonoprazanMakes it, makes the active ingredient, tests it and packages it Phathom Pharmaceuticals Inc. 81520-250

FDA inspection history

EndedResultProgramProblems noted
Nov 17, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 18, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 17, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 29, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 30, 2015Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 16, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 12, 2012Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 29, 2010Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 8, 2009No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture; label; manufacture; pack; relabel; repack.