Lions Eye Institute for Transplant and Research, Inc. – FDA 483, Jun 8, 2026

An FDA inspection of Lions World Vision Institute in Tampa, FL, an HCT/P establishment, revealed significant deficiencies in donor eligibility determination and record-keeping for ocular tissues. The firm failed to deem donors with sepsis ineligible and had inadequate procedures for donor screening, leading to the distribution of potentially unsafe tissues. Additionally, donor screening records lacked sufficient detail to justify eligibility decisions for donors with sepsis.