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992746

Intas Pharmaceuticals Limited — FEI 3004011473

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 19, 2016
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Taluka Sanand, Ahmedabad (India)

Facility

Other inspections at this facility

  • 1191818 (OAI Fri Dec 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1119170 (VAI Fri Feb 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1092798 (VAI Tue May 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 910188 (NAI Fri Dec 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 847008 (NAI Thu Jun 27 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
145221 CFR 211.113(b)Validation lacking for sterile drug products
360321 CFR 211.160(b)Scientifically sound laboratory controls