FDA 483 - Allergan Pharmaceuticals Ireland - January 30, 2025

Allergan Pharmaceuticals Ireland Unlimited, a drug product manufacturer in Westport, Ireland, was cited for multiple deficiencies during an FDA inspection. The observations included inadequate visual inspection rejection limits, insufficient laboratory test procedures for endotoxin, and a lack of cleaning validation for indirect product contact parts. Further issues were noted in environmental monitoring for aseptic processing areas and shipping validation for samples.