FDA 483 - Jeron Electronic Systems Inc. - June 20, 2019

Jeron Electronic Systems Inc. in Niles, IL, was inspected by the FDA, resulting in eight observations related to significant deficiencies in their quality system. The firm failed to establish numerous critical procedures, including those for process control, design change, corrective and preventive actions, nonconformance, complaint handling, medical device reporting, and supplier controls. These issues indicate a broad lack of foundational quality system documentation and control for their nurse call systems.