FDA 483 - Surgical Appliance Industries Inc - May 10, 2022

Surgical Appliance Industries Inc, a medical device manufacturer in Cincinnati, OH, was cited for multiple quality system deficiencies during an FDA inspection. Observations primarily focused on inadequate procedures and documentation for nonconforming product, device history records, labeling, CAPA, acceptance activities, equipment maintenance, and process controls, particularly concerning seaming operations. This indicates significant issues with their quality management system implementation.