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812463

Sanofi Winthrop Industrie — FEI 1000610805

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 18, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Maisons Alfort (France)

Facility

Other inspections at this facility

  • 1181600 (VAI Fri Dec 03 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 992633 (VAI Mon Oct 31 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 904598 (NAI Fri Nov 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 705370 (VAI Fri Dec 10 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
119421 CFR 211.42(c)Defined areas of adequate size for operations
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures