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1210984

Zoetis Manufacturing & Research Spain, S.L. — FEI 3001748505

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 28, 2023
Fiscal Year
2023
Product Type
Veterinary
Project Area
Pre-Approval Eval. of Animal Drugs and Food Additives
Location
La Vall De Bianya (Spain)

Facility

Other inspections at this facility

  • 1214845 (VAI Fri Mar 12 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 924729 (NAI Fri Feb 06 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 803792 (VAI Thu Oct 18 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 574450 (VAI Tue Mar 17 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145221 CFR 211.113(b)Validation lacking for sterile drug products
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
358521 CFR 211.110(a)Control procedures to monitor and validate performance