FDA 483 - CSI Medical, INC dba Boyd Corporation - November 18, 2022

An FDA inspection of CSI Medical, INC dba Boyd Corporation in Gallatin, TN, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately control nonconforming products, lacking proper documentation for evaluation, disposition, and justification for use. Additionally, procedures for corrective and preventive actions were not adequately established or verified for effectiveness, indicating a systemic breakdown in quality assurance processes.