# Lions Eye Institute for Transplant and Research, Inc. – FDA 483, Jun 8, 2026

Source: https://www.keypedia.com/records/483/lions-eye-institute-for-transplant-and-research-inc/e430ad03-dd2c-4089-8381-200e7372f2be

> FDA 483 for Lions Eye Institute for Transplant and Research, Inc. on June 08, 2026. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Lions Eye Institute for Transplant and Research, Inc.
- Inspection Date: 2026-06-08
- Product Type: biologics
- Office Name: Florida District Office
- Summary: An FDA inspection of Lions World Vision Institute in Tampa, FL, an HCT/P establishment, revealed significant deficiencies in donor eligibility determination and record-keeping for ocular tissues. The firm failed to deem donors with sepsis ineligible and had inadequate procedures for donor screening, leading to the distribution of potentially unsafe tissues. Additionally, donor screening records lacked sufficient detail to justify eligibility decisions for donors with sepsis.

## Related Officers

- [Lesley Mae P. Lutao](https://www.keypedia.com/people/lesley-mae-p-lutao/bfdcc755-28e5-4caf-91f9-b9579df4731e)
- [Steen N. Graham](https://www.keypedia.com/people/steen-n-graham/e0ce4c37-b1f1-4d94-8071-2d89b74975fd)

Company: https://www.keypedia.com/companies/lions-eye-institute-for-transplant-and-research-inc/523377ce-b82c-4f69-b505-9be3edf33087

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9