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1191818

Intas Pharmaceuticals Limited — FEI 3004011473

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 2, 2022
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Taluka Sanand, Ahmedabad (India)

Facility

Other inspections at this facility

  • 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))
  • 992746 (VAI Wed Oct 19 2016 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
180921 CFR 211.160(a)Following/documenting laboratory controls
189021 CFR 211.165(e)Test methods
202721 CFR 211.192Investigations of discrepancies, failures
202821 CFR 211.192Extent of discrepancy, failure investigations
203121 CFR 211.194(a)Complete test data included in records
435721 CFR 211.166(a)Results not used for expiration dates, storage cond.