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1059331

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

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 17, 2018
Fiscal Year
2018
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))
  • 1017293 (OAI Tue Jul 04 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 919376 (VAI Tue Mar 03 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
113421 CFR 211.25(b)Supervisor Training/Education/Experience
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
189021 CFR 211.165(e)Test methods
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures