Drug factory · FDA FEI 3002807809

Takeda GmbH

Lehnitzstr. 70-98, Oranienburg, Germany

Germany: 1

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

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

7 drug inspections on record since 2008: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
DexlansoprazoleMakes it and tests it TWi Pharmaceuticals, Inc., Takeda Pharmaceuticals America, Inc. 24979-703, 24979-704, 64764-171 +1
Glimepiride and PioglitazoneMakes it, tests it and packages it Prasco Laboratories, Takeda Pharmaceuticals America, Inc. 66993-821, 66993-822, 64764-302 +1
PantoprazoleMakes it, tests it, packages it and labels it Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0008-0841, 0008-0843, 0008-0844

FDA inspection history

EndedResultProgramProblems noted
Nov 28, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 30, 2020Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 16, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 11, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 15, 2013Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 16, 2011No problems foundDrug Quality Assurance—
Nov 6, 2008No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; label; manufacture; pack.