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800619

Aurobindo Pharma Limited — FEI 3004021263

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 21, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Sangareddy (India)

Facility

Other inspections at this facility

  • 1219023 (VAI Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028769 (VAI Fri Sep 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 909414 (NAI Tue Dec 09 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 711843 (OAI Wed Dec 22 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
188321 CFR 211.165(a)Testing and release for distribution
188521 CFR 211.165(b)Microbiological testing
241921 CFR 211.198(a)Complaint Handling Procedure
360321 CFR 211.160(b)Scientifically sound laboratory controls