FDA 483 - ARNA Pharma Pty., Ltd. - October 17, 2025

An FDA inspection of ARNA Pharma Pty., Ltd. in Frenchs Forest, Australia, revealed significant deficiencies in quality control and data integrity. The firm failed to thoroughly investigate out-of-specification results and implement corrective actions, and lacked appropriate controls over computer systems and written procedures for the quality control unit. These issues indicate a serious breakdown in the firm's quality management system.