FDA 483 - Fournier Laboratories Ireland, Ltd. (Abbvie Cork) - September 12, 2023

An FDA inspection of Fournier Laboratories Ireland Limited in Carrigtwohill, County Cork, Ireland, revealed three significant observations. The firm was cited for inadequate in-process testing during process performance qualification, insufficient cleaning and disinfecting procedures for production rooms, and the use of a non-validated spreadsheet for critical data transformation in release testing. These issues indicate deficiencies in quality control and data integrity practices.