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1205340

ACS Dobfar SPA (Plant #2) — FEI 3002806297

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 16, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tribiano (Italy)

Facility

Other inspections at this facility

  • 1194303 (VAI Fri Dec 03 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1099286 (VAI Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 952659 (NAI Fri Nov 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 842418 (VAI Thu Jul 04 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 667123 (VAI Mon May 10 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
145221 CFR 211.113(b)Validation lacking for sterile drug products
358521 CFR 211.110(a)Control procedures to monitor and validate performance