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Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank failed to comply with federal regulations governing human cells, tissues, and cellular products (HCT/Ps) during an FDA inspection conducted in January-February 2024. The company improperly determined five donors as eligible between January 2021 and January 2024 despite documented evidence of sepsis or other communicable disease risk factors that should have rendered them ineligible under 21 CFR 1271.75(a)(1), resulting in distribution of non-compliant ocular tissue products. These violations represented significant deviations from the regulatory requirements established under 21 CFR Part 1271 and the Public Health Service Act.