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1141156

Zoetis LLC — FEI 3010146372

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 3, 2021
Fiscal Year
2021
Product Type
Veterinary
Project Area
Pre-Approval Eval. of Animal Drugs and Food Additives
Location
Kalamazoo, MI (United States)

Facility

Other inspections at this facility

  • 1230798 (VAI Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1088266 (NAI Thu Apr 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 987221 (NAI Fri Aug 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 931788 (NAI Mon Jun 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874793 (VAI Thu Apr 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
110521 CFR 211.22(d)Procedures not in writing, fully followed
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
358521 CFR 211.110(a)Control procedures to monitor and validate performance