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978909

Lonza Biologics Plc — FEI 1000583959

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 24, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Slough (United Kingdom)

Facility

Other inspections at this facility

  • 1202907 (VAI Thu Oct 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1097017 (VAI Wed Sep 05 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 801062 (VAI Mon Sep 24 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145021 CFR 211.113(a)Procedures for non-sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures