FDA 483 - Newman Medical - September 25, 2024

An FDA inspection of Newman Medical, a medical device manufacturer in Arvada, CO, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for corrective and preventive actions (a repeat observation), servicing activities, design changes, and acceptance activities. Additionally, the inspection found issues with maintaining device history records and a complete lack of device master records for its Class 2 finished devices.