FDA 483 - Aurolife Pharma LLC - August 26, 2022

An FDA inspection of Aurolife Pharma LLC in Durham, NC, from August 22-26, 2022, revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The company's CAPA process failed to ensure the effectiveness of actions taken and did not adequately consider their potential adverse effects on finished products. This indicates a moderate severity issue related to quality system controls.