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874281

Roche Diagnostics GmbH — FEI 3002806559

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 4, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Mannheim (Germany)

Facility

Other inspections at this facility

  • 1177109 (VAI Fri Oct 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
441221 CFR 211.194(a)(7)Signatures and dates--person who performs test