FDA 483 - Lions Eye Bank For Long Island - August 03, 2023

The FDA inspected Lions Eye Bank For Long Island, an ocular tissue bank in Valley Stream, NY, and observed significant deficiencies. The inspection revealed failures in maintaining an adequate tracking system for HCT/Ps, including issues with electronic inventory records and standard operating procedures. Additionally, the firm failed to maintain records concurrently with each step and exhibited inaccuracies and legibility problems in tissue return documentation.