Home / Inspections / 850924

850924

Actavis Italy Spa A Socio Unico — FEI 3001116953

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 27, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Nerviano (Italy)

Facility

Other inspections at this facility

  • 1119381 (VAI Fri May 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083251 (VAI Fri Mar 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010790 (NAI Tue Dec 06 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 942841 (VAI Fri Sep 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 741518 (NAI Fri Jul 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
143321 CFR 211.42(c)(10)(iii)Air Supply
145221 CFR 211.113(b)Validation lacking for sterile drug products
200921 CFR 211.188Prepared for each batch, include complete information