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1079307

Lupin Limited — FEI 3007549629

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 25, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pithampur (India)

Facility

Other inspections at this facility

  • 1012540 (OAI Fri May 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 911036 (OAI Fri Jan 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 789247 (NAI Fri Jun 22 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 636980 (VAI Wed Nov 18 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
117721 CFR 211.63Equipment Design, Size and Location
126321 CFR 211.68(b)Computer control of master formula records
180921 CFR 211.160(a)Following/documenting laboratory controls
202721 CFR 211.192Investigations of discrepancies, failures
438221 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up