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1040233

Cohance Lifesciences Limited — FEI 3008768274

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 6, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Medchal-Malkajgiri (India)

Facility

Other inspections at this facility

  • 1100953 (VAI Tue Aug 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 980924 (VAI Tue Jul 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 853289 (VAI Fri Oct 11 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
358321 CFR 211.110(a)Written in-process control procedures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications