FDA 483 - Allergan Pharmaceuticals Ireland - January 30, 2025

Between January 23 and January 30, 2025, the FDA conducted an inspection of Allergan Pharmaceuticals Ireland Unlimited at its facility in Westport, County Mayo, Ireland. The resulting Form 483 details five primary areas of concern regarding the site"s drug product manufacturing and quality control systems. Major violations include an inadequate visual inspection process that failed to establish total rejection limits for critical, major, and minor defects. Additionally, the facility lacked written procedures for endotoxin testing on specific drug product cartridges and failed to provide data supporting sample hold times. The inspection also identified a lack of cleaning validation for indirect product contact parts, such as tweezers and gaskets, and noted deficiencies in environmental monitoring procedures regarding the timing of sample readings post-refrigeration. Finally, the firm had no standardized procedures for packaging samples for shipment to external testing laboratories. These observations indicate potential non-compliance with Current Good Manufacturing Practice (CGMP) standards. Although these findings do not represent a final agency determination, Allergan is required to respond to the FDA with corrective actions or objections to address the identified gaps in their quality and manufacturing oversight.