FDA WARNING_LETTER - Indiana Lions Eye Bank, Inc. (dbA VisionFirst Indiana Lions Eye Bank) - February 01, 2024

On June 10, 2024, the FDA issued a Warning Letter to Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank, following an inspection from January 22 to February 1, 2024. The inspection revealed significant deviations from 21 CFR Part 1271 regulations for human cells, tissues, and cellular and tissue-based products (HCTPs).

The primary violation cited was the failure to determine as ineligible five ocular HCT/P donors with documented diagnoses or clinical evidence of sepsis between January 2021 and January 2024, as required by 21 CFR 1271.75(d). Specific examples of donors with sepsis, septic shock, and multiple systemic responses to infection were detailed, including cases where HCT/Ps were distributed.

Additionally, the firm failed to ensure procedures complied with donor eligibility requirements (21 CFR 1271.47(a)). Their procedure, "SOP-DC-1, Transplant Tissue Exclusionary Criteria," and "Form F-DC-25 Sepsis Consult Flowchart," were found inadequate. They did not include all clinical evidence and systemic responses for sepsis evaluation, such as heart rate >90 bpm, respiratory rate >20 bpm, or more severe signs like unexplained hypoxemia, elevated lactate, oliguria, altered mentation, and hypotension. The flowchart also