FDA 483 - IRAY IMAGING LLC - October 24, 2025

IRAY IMAGING LLC, a medical device contract manufacturer in Solon, OH, was inspected by the FDA from October 20-24, 2025. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for corrective and preventive actions, control of nonconforming product, incoming product acceptance, and design transfer. These issues indicate a systemic lack of robust quality management practices.