Home / Inspections / 1079858

1079858

Emcure Pharmaceuticals Limited — FEI 3005151215

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 20, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pune (India)

Facility

Other inspections at this facility

  • 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))
  • 912371 (OAI Wed Feb 04 2015 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
193321 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
202721 CFR 211.192Investigations of discrepancies, failures
240121 CFR 211.194(a)(4)Complete Test Data