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Takeda GmbH, Plant Oranienburg, Oranienburg, Germany – FDA Inspections

Inspection records and compliance data for Takeda GmbH, Plant Oranienburg in Oranienburg. 7 FDA inspections on record, 1 Form 483, last inspected November 28, 2025.

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Company Profile

This profile covers Takeda GmbH, Plant Oranienburg based in Oranienburg, Germany.

FDA Inspection History

FDA inspections
7
OAI
0
VAI
5
NAI
2
Form 483s
1
Warning letters
0

First inspected November 6, 2008. Last inspected November 28, 2025.

FDA inspections (7)

DateResultFDA center(s)Insp. #
November 28, 2025VAIHuman Drugs · Drug Quality Assurance1309958
October 30, 2020VAIHuman Drugs · Drug Quality Assurance1156027
March 16, 2018VAIHuman Drugs · Drug Quality Assurance1047651
March 11, 2016VAIHuman Drugs · Drug Quality Assurance969059
November 15, 2013VAIHuman Drugs · Drug Quality Assurance869665
September 16, 2011NAIHuman Drugs · Drug Quality Assurance744981
November 6, 2008NAIHuman Drugs · Drug Quality Assurance550579
FDA documents

Form 483s (1)

  • Form 483s · March 16, 2018
People (1)
Kenneth E. Felkley
Person
Related Companies (10)

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Thymoorgan Pharmazie Gmbh
Alphapharm Pty, Ltd.
AstraZeneca Nijmegen B.V.
Watson Pharma Private Limited
Bora Pharmaceuticals Laboratories, Inc
Glenmark Pharmaceuticals Limited
AstraZeneca Pharmaceuticals LP
Cadila Pharmaceuticals Limited
IBSA Institut Biochimique SA
Merck Serono S.p.A.
Company Information

Name

Takeda GmbH, Plant Oranienburg

FEI Number

3002807809

Address

Lehnitzstr. 70-98, Oranienburg, Germany

Country

Germany

ID: c72ad117-1d9b-474a-8d1a-c4d0e81e9ba8

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