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912371

Emcure Pharmaceuticals Limited — FEI 3005151215

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 4, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pune (India)

Facility

Other inspections at this facility

  • 1079858 (OAI Wed Feb 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1075227 (NAI Tue Oct 30 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023101 (OAI Thu Aug 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 867389 (VAI Fri Feb 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 834734 (VAI Fri Apr 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126321 CFR 211.68(b)Computer control of master formula records
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
135821 CFR 211.100(b)SOPs not followed / documented
142121 CFR 211.42(c)(10)Aseptic Processing Area
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
360321 CFR 211.160(b)Scientifically sound laboratory controls