FDA 483 - Aeon Biotherapeutics Corp. - March 07, 2025

Aeon Biotherapeutics Corp., a manufacturer in New Taipei City, Taiwan, was inspected by the FDA from March 3-7, 2025. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning corrective and preventive actions, control of nonconforming products, and contamination prevention procedures. These issues indicate a lack of adequate controls to ensure product quality and compliance with regulatory requirements.