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1051545

Merck Serono SA — FEI 3002807447

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 9, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Aubonne (Switzerland)

Facility

Other inspections at this facility

  • 1209187 (NAI Tue May 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1122463 (VAI Tue Feb 18 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 947757 (VAI Fri Nov 06 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 857686 (VAI Tue Nov 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 811249 (VAI Fri Nov 16 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
438821 CFR 211.198(a)Complaints reviewed by Quality Control Unit