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789195

Unichem Laboratories Ltd. — FEI 3004082076

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 15, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ghaziabad (India)

Facility

Other inspections at this facility

  • 1230023 (NAI Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102985 (VAI Fri Aug 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1087477 (NAI Fri Mar 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053321 (NAI Fri Apr 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1008000 (VAI Fri Mar 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
113321 CFR 211.25(a)GMP Training Frequency
136121 CFR 211.100(a)Absence of Written Procedures
189021 CFR 211.165(e)Test methods
192221 CFR 211.166(a)(4)Testing in same container - closure system