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FDA Inspection 1309958 — Takeda GmbH, Plant Oranienburg

Takeda GmbH, Plant Oranienburg — FEI 3002807809

The FDA completed an inspection of Takeda GmbH, Plant Oranienburg on November 28, 2025 in Oranienburg. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 28, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Oranienburg (Germany)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1156027 (VAI Fri Oct 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1047651 (VAI Fri Mar 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 969059 (VAI Fri Mar 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 869665 (VAI Fri Nov 15 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 744981 (NAI Fri Sep 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources