FDA 483 - James Consolidated, Inc. - November 03, 2020

An FDA inspection of James Consolidated, Inc. in Concord, CA, revealed significant deficiencies in their quality system for manufacturing and distributing The Volkner Turning System, a Class 2 medical device. The firm failed to establish and maintain numerous critical procedures, including those for corrective and preventive actions, device master records, quality audits, supplier control, complaint handling, management review, design control, non-conforming product, and medical device reporting. Additionally, the firm did not document acceptance activities or complaints.