FDA 483 - Luminance Medical Ventures Incorporated - April 08, 2025

Luminance Medical Ventures Incorporated, a specification developer and complaint file establishment in Dallas, TX, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding the establishment and implementation of adequate procedures for complaint handling and corrective and preventive actions. These issues indicate a lack of proper controls for managing product quality and addressing nonconformities.