FDA 483 - Lions Medical Eye Bank & Research Center of Eastern VA - February 16, 2023

An FDA inspection of Lions Medical Eye Bank & Research Center of Eastern VA revealed significant deficiencies across its operations. The firm failed to validate process changes, lacked established procedures for critical HCT/P manufacturing steps, and did not adequately investigate positive environmental monitoring cultures. Additionally, the facility did not maintain or calibrate equipment according to established procedures, indicating a broad lack of control over its HCT/P processing and quality systems.