FDA 483 - IRAY IMAGING LLC - October 24, 2025

An FDA inspection conducted at IRAY IMAGING LLC from October 20-24, 2025, identified several significant issues indicating a lack of adequate quality system controls. The inspection, performed under the Federal Food, Drug, and Cosmetic Act, found four primary observations requiring the company's attention. Firstly, the company's procedures for corrective and preventive actions (CAPA) were insufficient, with failures to complete verification of effectiveness before CAPA closure, inconsistent documentation of corrective actions, and inadequate definitions for CAPA initiation. Secondly, procedures for controlling nonconforming product were not adequately established, evidenced by unaddressed nonconforming labeling, insufficient justification for foregoing defect investigations, lack of documentation for rework activities, and failure to record the status of replaced nonconforming components. Additionally, the firm's procedures for accepting incoming product were deficient, including incorrect sample sizes used during inspection and supplier reports not reflecting current drawing revisions. Finally, design transfer procedures were found to be inadequately established, particularly regarding the proper incorporation of customer-requested design changes into manufacturing processes and product evaluations before production release. IRAY IMAGING LLC is responsible for addressing these observations to ensure compliance with federal medical device regulations and has committed to correcting all identified deficiencies.