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1160748

Cronus Pharma Specialities India Pvt Ltd — FEI 3015283219

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 15, 2022
Fiscal Year
2022
Product Type
Veterinary
Project Area
Pre-Approval Eval. of Animal Drugs and Food Additives
Location
Hyderabad (India)

Facility

Other inspections at this facility

  • 1282274 (VAI Wed Aug 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1216310 (VAI Tue Aug 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1195331 (OAI Wed Jan 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
358521 CFR 211.110(a)Control procedures to monitor and validate performance