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1031652

Glenmark Pharmaceuticals Limited — FEI 3005757050

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 11, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Solan (India)

Facility

Other inspections at this facility

  • 1172425 (OAI Wed Jun 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1070594 (NAI Fri Sep 21 2018 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
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
194221 CFR 211.180(e)Records reviewed annually
202721 CFR 211.192Investigations of discrepancies, failures
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings