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

Donor Alliance, Inc., a human tissue establishment in Denver, Colorado, underwent an FDA inspection from January 6 to January 15, 2026. The inspection identified several critical deficiencies in the firm’s donor eligibility and safety protocols. A primary concern was the failure to adequately screen donor medical records for communicable diseases. Specifically, a donor with documented sepsis was incorrectly cleared for donation, and the tissue was later transplanted. The firm also failed to thoroughly investigate reports of post-operative infections in recipients. Additional violations included deficient written procedures for evaluating risks like West Nile Virus and Hepatitis B, as well as the use of third-party protocols that were not verified for regulatory compliance. Environmental controls were also found to be insufficient; blood samples and medical supplies were stored in unmonitored or incorrectly monitored areas, risking contamination or degradation. Furthermore, the quality program did not ensure that Medical Directors and consultants were properly trained in screening and record-keeping duties. These observations were issued under the regulatory framework of the Food and Drug Administration regarding human cells and tissues. Donor Alliance, Inc. is required to review these findings and provide a response to the FDA. This response should outline planned or implemented corrective actions to address the systemic failures in donor screening, environmental monitoring, and personnel training to ensure future compliance and public safety.