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

During an inspection conducted from September 7 to September 12, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Fournier Laboratories Ireland Limited, a drug product manufacturer located in Carrigtwohill, County Cork, Ireland. The inspection revealed several observations indicating deviations from Current Good Manufacturing Practices. Key issues included inadequate in-process testing during the Process Performance Qualification (PPQ) for certain capsules, where a critical unit operation was not tested according to established protocols. Furthermore, the cleaning and disinfection procedures for production rooms were found to be insufficient, with disinfectant efficacy studies failing to challenge all relevant facility surfaces and the disinfectant not tested against required compendial microorganisms. Finally, data transformation for capsule release testing was performed using an unvalidated spreadsheet. Raw data was manually transcribed from printed reports into an Excel spreadsheet, and a separate manual calculation was needed to determine relative standard deviation, raising concerns about data integrity and validation. These observations highlight the need for Fournier Laboratories Ireland Limited to implement comprehensive corrective and preventive actions to ensure compliance with regulatory standards for drug manufacturing. The company is required to formally respond to the FDA addressing each observation with detailed plans for remediation.