FDA 483 - Donor Alliance, Inc. - January 15, 2026

An FDA inspection of Donor Alliance, Inc. in Denver, CO, a human tissue establishment, revealed significant deficiencies in donor screening and quality control processes. The firm failed to adequately screen donors for communicable diseases, including sepsis, and did not properly investigate adverse reactions. Additionally, procedures for donor eligibility, testing, and storage of supplies were found to be inadequate or not followed, and personnel training was insufficient.