New Mexico Lions Sight Conservation Foundation, Inc. dba New Mexico Lions Eye Bank — FDA Warning Letter Findings

In response to Observation 1, your disagreement that the donors were septic at the time of the death does not account for the donors’ medical records with documented diagnoses and clinical evidence of sepsis, including systemic responses to infection, during their hospital stay immediately preceding death. Your response states, “Quite simply, one cannot be septic and have negative blood cultures. And the practice of paper sepsis has proven over and over and over and over to…

Failure to determine as ineligible a donor who is identified as having a risk factor for, or clinical evidence of, any of the relevant communicable disease agents or diseases for which screening is required under 21 CFR 1271.75(a)(1) [21 CFR 1271.75(d)]. You failed to determine as ineligible two donors of ocular HCT/Ps with a documented diagnosis or clinical evidence of sepsis, including two or more systemic responses to infection, documented within their available medical…

Failure to ensure procedures are in compliance with the donor eligibility requirements within Subpart C – Donor Eligibility of 21 CFR Part 1271 [21 CFR 1271.47(a)]. For example, your procedures, “T-710 Donor Screening Criteria,” “TF-710-01 Donor Screening Criteria Guide,” and “T-720 Donor Eligibility Determination,” are used to determine donor eligibility, and “TF-710-02 Sepsis Algorithm,” is used to determine a donor’s risk for sepsis and if an infectious disease consult is…