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FDA Inspection 1123212 — Newchem S.P.A.

Newchem S.P.A. — FEI 3005786129

The FDA completed an inspection of Newchem S.P.A. on November 29, 2018 in Verona. 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
November 29, 2018
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Verona (Italy)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1287116 (VAI Thu Mar 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1094538 (VAI Fri Feb 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 981582 (VAI Fri Jul 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 873482 (VAI Fri Mar 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 675736 (VAI Fri Jul 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources