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1017293

Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. — FEI 3002807242

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 4, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Aprilia (Italy)

Facility

Other inspections at this facility

  • 1254712 (VAI Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1235389 (VAI Tue Sep 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1148007 (VAI Fri Feb 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1059331 (VAI Tue Jul 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 919376 (VAI Tue Mar 03 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
192221 CFR 211.166(a)(4)Testing in same container - closure system
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
362921 CFR 211.170(b)Reserve samples identified, representative, stored