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FDA Inspection 1194565 — Hikma Pharmaceuticals USA Inc.

Hikma Pharmaceuticals USA Inc. — FEI 3012279857

The FDA completed an inspection of Hikma Pharmaceuticals USA Inc. on December 15, 2022 in Bedford, OH. 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 15, 2022
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bedford, OH (United States)

Facility

Other inspections at this facility

  • 1220071 (VAI Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1161837 (VAI Mon Feb 07 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1117006 (VAI Fri Jan 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 990058 (NAI Thu Oct 13 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

  • Injunction (311) (Thu Jan 31 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources