FDA 483 - Amcor Rigid Packaging USA, LLC - January 12, 2023

An FDA inspection of Amcor Rigid Packaging USA, LLC in Fort Worth, TX, from January 9-12, 2023, revealed significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for controlling nonconforming product, managing suppliers, and evaluating customer complaints for Medical Device Reporting events. These issues indicate a lack of adherence to established quality requirements and regulatory obligations.