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FDA Inspection 1177109 — Roche Diagnostics GmbH

Roche Diagnostics GmbH — FEI 3002806559

The FDA completed an inspection of Roche Diagnostics GmbH on October 29, 2021 in Mannheim. 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
October 29, 2021
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Mannheim (Germany)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1103444 (VAI Thu Aug 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1057452 (NAI Thu Apr 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 993103 (NAI Fri Nov 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 973782 (NAI Fri Apr 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 928460 (NAI Wed May 27 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources