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919376

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

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 3, 2015
Fiscal Year
2015
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))
  • 1017293 (OAI Tue Jul 04 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
172821 CFR 211.87Retest of approved components/containers/closures
197721 CFR 211.182Dedicated equipment: records part of batch record
220521 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
360321 CFR 211.160(b)Scientifically sound laboratory controls
362921 CFR 211.170(b)Reserve samples identified, representative, stored
439121 CFR 211.180(e)(2)Items to cover on annual reviews
440221 CFR 211.192Written record of investigation incomplete