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1101549

Choksi Laboratories Limited — FEI 3006091736

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 6, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Indore (India)

Facility

Other inspections at this facility

  • 1053312 (VAI Wed Apr 25 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 974173 (VAI Wed Jun 01 2016 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
126321 CFR 211.68(b)Computer control of master formula records
187921 CFR 211.180(c)Records not made readily available to FDA
202721 CFR 211.192Investigations of discrepancies, failures
360221 CFR 211.160(a)Deviations from laboratory control requirements