FDA 483 - Janssen Sciences Ireland UC - April 30, 2021

During an inspection from April 26-30, 2021, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Janssen Sciences Ireland UC, a drug substance manufacturer located in Ringaskiddy, Co. Cork, Ireland. The inspection revealed that the company did not adequately investigate invalid assays, despite its internal Standard Operating Procedures (SOPs) requiring further investigation when invalid assay rates exceeded a specific internal threshold of (b)(4)%. The main issue highlighted was a consistent failure to implement adequate investigations or corrective actions for high invalid assay rates. Specifically, the FDA observed instances where a particular assay exhibited an invalid rate of (b)(4)% and other (b)(4) bioassay rates were reported as (b)(4) in specific reporting periods. Additionally, a different (b)(4) assay registered an invalid rate of (b)(4)% for a specific period, prompting an internal Quality Investigation. These examples indicate a gap in the company's quality system regarding the thorough investigation and management of analytical data discrepancies. This observation suggests potential deviations from the regulatory expectations for Good Manufacturing Practices (GMP), particularly concerning laboratory controls and quality assurance processes. While the Form 483 is an observation document and not a final determination, Janssen Sciences Ireland UC is implicitly required to address these findings comprehensively. This includes conducting thorough root cause analyses and implementing robust corrective and preventive actions to ensure the reliability and integrity of their assay results and overall compliance with regulatory standards.