FDA 483 - CMI Health, Inc. - May 30, 2025

CMI Health, Inc. in Alpharetta, GA, was cited with five observations on a Form 483, indicating significant deficiencies in their quality management system for medical devices. The inspection revealed inadequate complaint handling procedures, a complete absence of design controls, and failures in supplier evaluation, internal audits, and document control. These issues collectively point to a systemic lack of adherence to regulatory requirements.