FDA 483 - S-Comm, Inc. - May 17, 2023

An FDA inspection of S-Comm, Inc. in Raytown, MO, a specification developer for the Class II UbiDuo product, identified six significant quality system deficiencies. The firm failed to establish and document critical procedures for design control, corrective and preventive actions, complaint handling, purchasing controls, and nonconforming product, and also lacked documented personnel training. These observations indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.