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1102691

Boehringer Ingelheim Pharma GmbH & Co. Kg — FEI 3002806518

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 19, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Biberach An Der Riss (Germany)

Facility

Other inspections at this facility

  • 1208927 (VAI Fri Jul 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107587 (NAI Thu Aug 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1086418 (VAI Fri Apr 05 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 881697 (VAI Fri May 30 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 826498 (NAI Tue Mar 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures