FDA Inspection 935111 — Hikma Pharmaceuticals LLC

Hikma Pharmaceuticals LLC — FEI 3002806351

The FDA completed an inspection of Hikma Pharmaceuticals LLC on June 25, 2015 in Amman. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 25, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Amman (Jordan)

Citations

IDCFRDescription
188321 CFR 211.165(a)Testing and release for distribution
189021 CFR 211.165(e)Test methods