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1275919

Daiichi Sankyo Europe GmbH — FEI 3003282622

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 18, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pfaffenhofen A.D.Ilm (Germany)

Facility

Other inspections at this facility

  • 1073797 (NAI Fri Oct 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 882156 (NAI Thu May 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 802508 (NAI Thu Sep 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 649526 (NAI Fri Jan 29 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records