FDA 483 - Nexus CMF, LLC - September 25, 2019

Nexus CMF, LLC, a medical device specification developer in Cottonwood Heights, UT, was cited with five observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality system, including inadequate procedures and documentation for complaint handling, corrective and preventive actions, nonconforming product control, personnel training, and supplier evaluation. These issues indicate a systemic failure to adhere to established quality system requirements.