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962557

Glenmark Pharmaceuticals Limited — FEI 3008565058

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 26, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dhar (India)

Facility

Other inspections at this facility

  • 1122868 (NAI Tue Feb 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107098 (NAI Fri Sep 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053034 (VAI Thu May 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028538 (NAI Sat Aug 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935717 (VAI Fri Jul 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
432521 CFR 211.110(a)Control procedures fail to include the following
434021 CFR 211.142Written warehousing procedures established/followed