FDA 483 - Surgical Appliance Industries Inc - October 18, 2023

An FDA inspection of Surgical Appliance Industries Inc. in Cincinnati, OH, revealed significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for corrective and preventive actions, complaint handling, and control of nonconforming product. These issues, including repeat observations from a previous inspection, indicate a systemic lack of adherence to quality system requirements.