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

Aeon Biotherapeutics Corp. in New Taipei City, Taiwan, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate corrective and preventive action procedures, insufficient control over nonconforming products, and poorly defined contamination prevention (gowning) procedures. These issues indicate a lack of robust quality management practices.