FDA 483 - Gynex Corporation - January 06, 2020

Gynex Corporation, a medical device manufacturer in Redmond, WA, was inspected by the FDA from January 2-6, 2020. The inspection revealed significant deficiencies in their quality system, particularly concerning corrective and preventive actions, complaint handling, equipment calibration, supplier evaluation, and nonconforming product disposition. The firm failed to adequately establish and follow procedures for these critical areas.