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1217144

OrBion Pharmaceuticals Private Limited — FEI 3004540907

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 8, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chennai (India)

Facility

Other inspections at this facility

  • 1091278 (VAI Fri May 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 934390 (VAI Wed Jun 03 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 841047 (NAI Fri Jun 14 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 732080 (VAI Thu Apr 07 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
136121 CFR 211.100(a)Absence of Written Procedures
180921 CFR 211.160(a)Following/documenting laboratory controls