FDA 483 - Lions Eye Bank of Texas at Baylor College of Medicine - January 29, 2025

An FDA inspection of Lions Eye Bank of Texas at Baylor College of Medicine, a human tissue-eye bank, revealed deficiencies in temperature monitoring practices. The firm failed to periodically review recorded storage temperatures and document the cause of temperature excursions for human tissue products. Additionally, the relevant SOP did not instruct personnel to document these causes.