Lions Eye Bank For Long Island – FDA 483, Aug 3, 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.
ID · d682839e-b30e-438f-a1d5-5a520bca91d7
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.