FDA 483 - Rocky Mountain Lions Eye Bank - September 27, 2024

An FDA inspection of Rocky Mountain Lions Eye Bank in Aurora, CO, revealed critical deficiencies in donor eligibility determination and screening processes. The firm failed to properly identify and exclude donors with risk factors for communicable diseases, including sepsis, Zika Virus, and West Nile Virus. Additionally, the firm's written procedures were inadequate to ensure compliance with donor eligibility requirements, and its quality program did not ensure proper training for personnel involved in donor screening.