FDA 483 - Quadric BioMed, LLC - December 16, 2024

An FDA inspection of Quadric BioMed, LLC, a medical device specification developer in Colorado Springs, CO, revealed significant deficiencies in their quality management system. The firm failed to adequately establish and follow procedures for vendor control, internal quality audits, management reviews, and employee training. These issues indicate a systemic lack of documented processes and records essential for regulatory compliance.