FDA 483 - New Mexico Lions Sight Conservation Foundation, Inc. - February 28, 2024

An FDA inspection of New Mexico Lions Sight Conservation Foundation, Inc. identified significant issues regarding donor eligibility determinations. The firm failed to deem ineligible donors with risk factors or clinical evidence of communicable disease agents, specifically sepsis. Additionally, the firm's procedures for donor eligibility, particularly concerning sepsis screening and medical record review, were found to be inadequate.