FDA WARNING_LETTER - New Mexico Lions Sight Conservation Foundation, Inc. - February 28, 2024

The FDA issued a Warning Letter to New Mexico Lions Sight Conservation Foundation, Inc., also known as New Mexico Lions Eye Bank, following an inspection from February 23-28, 2024. The inspection revealed significant deviations from HCT/P regulations (21 CFR Part 1271).

Key violations include: 1. **Failure to determine donor ineligibility for sepsis (21 CFR 1271.75(d)):** The firm failed to deem two ocular HCT/P donors ineligible despite documented diagnoses and clinical evidence of sepsis, including systemic responses to infection, in their medical records immediately preceding death. Examples cited were Donor (b)(6), (b)(7)(C) (urosepsis) and Donor (b)(6), (b)(7)(C) (septic shock). These are core CGTP deviations requiring deviation reports per 21 CFR 1271.350(b). 2. **Failure to ensure compliant donor eligibility procedures (21 CFR 1271.47(a)):** The firm's procedures ("T-710 Donor Screening Criteria," "TF-710-01 Donor Screening Criteria Guide," "T-720 Donor Eligibility Determination," and "TF-710-02 Sepsis Algorithm") do not adequately incorporate all clinical evidence and systemic responses for sepsis risk evaluation, such