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

Amcor Rigid Packaging USA, LLC in Fort Worth, TX, a contract manufacturer, received a Form FDA-483 following an inspection. The primary observation concerned inadequately established procedures for the review and disposition of nonconforming product. Specifically, the firm failed to document justification for using nonconforming product in multiple nonconformance reports.