Drug factory · FDA FEI 3002806414

Baxter Deutschland GmbH

Artur-Ladebeck-Str. 136, Bielefeld, Germany

Germany: 1

Problems found, fixed voluntarily at FDA's last inspection, May 28, 2025.

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

5 drug inspections on record since 2011: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
2-Mercaptoethanesulfonic AcidMakes the active ingredient Bamboo US Bidco LCC, Baxter Healthcare Corporation 83703-559, 0338-1305, 0338-1307 +3
4-HydroxycyclophosphamideMakes the active ingredient Baxter Healthcare Corporation 10019-982, 10019-984
BendamustineMakes the active ingredient Baxter Healthcare Corporation 10019-079
IfosfamideMakes the active ingredient Baxter Healthcare Corporation 0338-3991, 0338-3993, 10019-925 +3

FDA inspection history

EndedResultProgramProblems noted
May 28, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 11, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 14, 2018No problems foundDrug Quality Assurance—
Jan 22, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Aug 26, 2011No problems foundDrug Quality Assurance—

Registered with FDA for: api manufacture.