FDA Inspection 1002463 — Allergan Pharmaceuticals Ireland

Allergan Pharmaceuticals Ireland — FEI 3002806285

The FDA completed an inspection of Allergan Pharmaceuticals Ireland on December 16, 2016 in Westport. 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
December 16, 2016
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Westport (Ireland)

Citations

IDCFRDescription
143321 CFR 211.42(c)(10)(iii)Air Supply
202621 CFR 211.192Quality control unit review of records