483
Lions Eye Bank of Texas at Baylor College of MedicineLions Eye Bank of Texas at Baylor College of Medicine – FDA 483, Jan 29, 2025
Record Details
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.
- Inspection date
- January 29, 2025
- Product type
- biologics
View Company Profile
ID · 1fdcbb62-caae-4970-a468-c9433f09bb02
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.