FDA Inspection 1216310 — Cronus Pharma Specialities India Pvt Ltd

Cronus Pharma Specialities India Pvt Ltd — FEI 3015283219

The FDA completed an inspection of Cronus Pharma Specialities India Pvt Ltd on August 29, 2023 in Hyderabad. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Veterinary.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 29, 2023
Fiscal Year
2023
Product Type
Veterinary
Project Area
Pre-Approval Eval. of Animal Drugs and Food Additives
Location
Hyderabad (India)

Citations

IDCFRDescription
109821 CFR 211.22(c)Approve or reject procedures or specs
126321 CFR 211.68(b)Computer control of master formula records