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1172425

Glenmark Pharmaceuticals Limited — FEI 3005757050

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 22, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Solan (India)

Facility

Other inspections at this facility

  • 1070594 (NAI Fri Sep 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031652 (VAI Sat Nov 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 929619 (VAI Fri May 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 802324 (NAI Fri Aug 24 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 643147 (VAI Fri Nov 13 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127021 CFR 211.68(b)input/output verification
136121 CFR 211.100(a)Absence of Written Procedures
202721 CFR 211.192Investigations of discrepancies, failures
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications