FDA 483 - Lions Medical Eye Bank & Research Center of Eastern VA - February 11, 2025

The FDA inspected Lions Medical Eye Bank & Research Center of Eastern VA in Norfolk, VA, an HCT/P establishment. The inspection revealed two significant issues related to the processing and storage of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Specifically, the firm failed to monitor environmental conditions during processing and did not establish acceptable temperature limits for HCT/P storage, potentially compromising product safety.