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1100840

Biocon Biologics Limited — FEI 3003981475

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 30, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bengaluru (India)

Facility

Other inspections at this facility

  • 1245708 (VAI Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1050980 (VAI Tue May 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1016114 (VAI Sat Jun 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 948968 (VAI Thu Oct 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 934266 (VAI Tue Jun 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
439921 CFR 211.186(b)(7)Theoretical yield statement including percentages
440221 CFR 211.192Written record of investigation incomplete