FDA 483 - MRI CARDIAC SERVICES INCORPORATED - February 24, 2022

MRI Cardiac Services Incorporated, a medical device manufacturer in Winston Salem, NC, was cited for significant deficiencies across its quality system during an FDA inspection. The firm failed to adequately establish procedures for design changes, maintain a complete design history file for its CardioVue System, and properly manage complaint investigations. Additionally, the inspection revealed issues with corrective and preventive action procedures, document control, quality audits, and management review of the quality system.