FDA 483 - Lions Eye Bank For Long Island - September 04, 2020

The FDA inspected Lions Eye Bank For Long Island, an ocular tissue bank, and found significant deficiencies across five observations. These included failures to report HCT/P deviations, inadequate environmental control system inspections, issues with tissue tracking, outdated procedures, and inaccurate records for ocular tissue handling. The findings indicate a lack of adherence to good tissue practices and proper documentation.