FDA 483 - AbbVie Ireland NL. B.V. - September 10, 2024

An FDA inspection of Abbvie Ireland NL B.V Ballytivnan in Sligo identified multiple significant deficiencies across its drug product manufacturing operations. Observations included inadequate procedures for preventing microbial contamination, insufficient visual inspection processes, and a deficient environmental monitoring program. The facility also exhibited poor maintenance, unqualified storage areas, and a lack of adherence to established SOPs, indicating a broad range of non-compliance issues that could impact product quality and sterility.