Catheter Robotics, Incorporated – FDA 483, Jul 2, 2025

Catheter Precision Inc. received an FDA Form 483 following an inspection conducted from June 30 to July 2, 2025. The primary observation noted by the Food and Drug Administration concerned inadequate adherence to established procedures for managing suppliers, specifically regarding ensuring that all purchased products and services meet specified requirements. The firm's "Supplier Management and Control Procedure" (Document 00-0100-038 Rev. 03) mandates documented re-evaluations for high-risk suppliers. However, investigators observed that Catheter Precision Inc. failed to conduct and document these required re-evaluations for two identified High-Risk Suppliers, A and B. This indicates a deviation from the company's own quality system for supplier management. While the FDA Form 483 serves as an alert to observed conditions and does not represent a final determination of compliance, it highlights a need for the company to review and improve its supplier control processes. The regulatory framework under which this inspection was conducted, Section 704(b) of the Federal Food, Drug, and Cosmetic Act, expects firms to conduct internal self-audits and implement corrective actions to address any violations of quality system requirements. Catheter Precision Inc. is expected to address these observations by implementing appropriate corrective actions to ensure consistent compliance with its supplier management procedures and overall quality system.