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FDA Inspection 1123992 — Fresenius Kabi iPSUM Srl

Fresenius Kabi iPSUM Srl — FEI 3005479678

The FDA completed an inspection of Fresenius Kabi iPSUM Srl on December 6, 2019 in Villadose. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 6, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Villadose (Italy)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1277643 (VAI Fri Jan 21 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1078083 (VAI Fri Dec 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 993733 (NAI Thu Nov 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854585 (VAI Fri Sep 27 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 712032 (VAI Fri Feb 11 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources