FDA 483 - Quasar Bio-Tech, Inc. - December 20, 2024

An FDA inspection of Quasar Bio-Tech, Inc. in Yorba Linda, CA, a specification developer, revealed significant deficiencies in its quality system. The firm failed to conduct internal audits, lacked proper supplier agreements, did not adequately evaluate complaints for Medical Device Reporting, and failed to maintain Design History Files. These issues indicate a systemic breakdown in maintaining a compliant quality management system.