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FDA Inspection 1254066 — Hikma Farmaceutica, (Portugal) S.A.

Hikma Farmaceutica, (Portugal) S.A. — FEI 3002807173

The FDA completed an inspection of Hikma Farmaceutica, (Portugal) S.A. on February 3, 2023 in Terrugem Snt. 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
February 3, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Terrugem Snt (Portugal)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1203129 (VAI Fri Apr 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1125050 (VAI Fri Mar 06 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1050480 (NAI Thu Mar 22 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 970483 (VAI Tue Apr 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 940389 (VAI Fri Jun 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources