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974363

Mitim SRL — FEI 3005746589

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 10, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Brescia (Italy)

Facility

Other inspections at this facility

  • 1266236 (VAI Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1109041 (VAI Fri Nov 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062263 (NAI Tue Jul 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878874 (VAI Tue Apr 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 753774 (NAI Tue Nov 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
189021 CFR 211.165(e)Test methods
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
440621 CFR 211.194(a)(2)Suitability of testing methods verified