FDA 483 - Amcor Rigid Packaging USA, LLC - July 11, 2025

During an FDA inspection conducted from July 9-11, 2025, Amcor Rigid Packaging USA, LLC, a contract manufacturer, received a Form FDA-483. The inspection identified a significant issue concerning the company's quality system for managing nonconforming products. Specifically, procedures outlining the responsibility for reviewing and authorizing the disposition of nonconforming materials were not adequately established. The most prominent observation noted that in seven out of eleven reviewed nonconformance reports, the firm failed to document the justification for using nonconforming product. While the online reports included authorization signatures and dates, they lacked the essential justification and evaluation of potential adverse effects associated with the use of such products. This indicates a gap in the company's adherence to critical quality control measures. Issued under the Federal Food, Drug, and Cosmetic Act, the FDA-483 emphasizes the firm's responsibility to conduct internal self-audits and implement corrective actions to address all identified quality system deficiencies and ensure ongoing compliance.