FDA 483 - Jazz Imaging - October 24, 2022

An FDA inspection of Jazz Imaging in San Jose, CA, from October 12-24, 2022, revealed significant deficiencies in its quality system as a medical device manufacturer. The firm failed to adequately document management reviews, training, supplier evaluations, process validations, equipment calibrations, quality audits, complaint investigations, and corrective and preventive actions. Additionally, the company did not perform required IQ/OQ/PQ for manufacturing equipment.