FDA Inspection 1056170 — Intas Pharmaceuticals Limited

Intas Pharmaceuticals Limited — FEI 3003157498

The FDA completed an inspection of Intas Pharmaceuticals Limited on Jun 8, 2018 in Ahmedabad. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Veterinary.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jun 8, 2018
Fiscal Year
2018
Product Type
Veterinary
Project Area
Pre-Approval Eval. of Animal Drugs and Food Additives
Location
Ahmedabad (India)

Citations

IDCFRDescription
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
202721 CFR 211.192Investigations of discrepancies, failures

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