FDA 483 - Alltrista Plastics, LLC - March 04, 2020

An FDA inspection of Alltrista Plastics, LLC, a contract manufacturer in Reedsville, PA, revealed significant deficiencies in their quality management system. The firm failed to adequately establish procedures for finished device acceptance, supplier monitoring, and corrective and preventive actions. These issues indicate a lack of control over product release, supplier quality, and complaint resolution processes.