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927215

Zydus Lifesciences Limited — FEI 3005430968

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 23, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Baddi (India)

Facility

Other inspections at this facility

  • 1123492 (NAI Mon Mar 09 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100892 (NAI Fri Jul 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007281 (NAI Wed Mar 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 808443 (VAI Fri Nov 09 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 709841 (VAI Fri Oct 08 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
188321 CFR 211.165(a)Testing and release for distribution
360221 CFR 211.160(a)Deviations from laboratory control requirements
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.