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1076343

Dr Reddy's Laboratories Limited — FEI 3009193040

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 15, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Devunipalavalasa (India)

Facility

Other inspections at this facility

  • 1230622 (VAI Fri May 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1122262 (NAI Fri Feb 14 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1018229 (VAI Fri Jun 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 904970 (NAI Fri Nov 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
135821 CFR 211.100(b)SOPs not followed / documented
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls