FDA 483 - Roslin Cell Therapies Limited - January 21, 2025

During an inspection conducted from January 13 to January 21, 2025, the U.S. Food and Drug Administration (FDA) cited ROSLIN CELL THERAPIES LIMITED for significant deviations from Current Good Manufacturing Practice (CGMP) regulations. The observations, detailed in an FDA Form 483, highlight critical issues across multiple operational areas. A primary concern involved inadequate control over aseptic processing, where manufacturing personnel were observed with compromised sterile gowning, including exposed skin from ill-fitting goggles in critical production environments. This raises serious questions about the prevention of microbiological contamination for sterile drug products. Furthermore, the inspection identified severe data integrity vulnerabilities. Electronic systems crucial for isolating cells during drug product manufacturing lacked fundamental safeguards such as access controls and audit trails. This deficiency was present despite the firm's own risk assessment acknowledging these gaps, impacting numerous batches, including those destined for the U.S. market. The company's quality control unit also exhibited procedural failures. A substantial number of deviations, classified as critical, major, and minor, were not closed within their established target timeframes, with some remaining open for extended periods. Additionally, the training program was found deficient as it lacked contemporaneous documentation of attendance, relying instead on an unvalidated system for recording training receipt. ROSLIN CELL THERAPIES LIMITED is now required to address these systemic issues comprehensively, implementing effective corrective and preventive actions to ensure compliance with regulatory standards for drug manufacturing.