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974173

Choksi Laboratories Limited — FEI 3006091736

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 1, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Indore (India)

Facility

Other inspections at this facility

  • 1101549 (VAI Fri Sep 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053312 (VAI Wed Apr 25 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 867346 (VAI Sun Jan 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 673062 (VAI Wed Jul 14 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
109821 CFR 211.22(c)Approve or reject procedures or specs
110521 CFR 211.22(d)Procedures not in writing, fully followed
181021 CFR 211.160(a)Lab controls established, including changes
240121 CFR 211.194(a)(4)Complete Test Data
360321 CFR 211.160(b)Scientifically sound laboratory controls