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FDA Warning Letter Explorer
FDA warning letter · Biologics

Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank

Issued · Posted by FDA

FDA published a close-out letter on Feb 12, 2026. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Between January 2021 and January 2024, you failed to determine as ineligible five 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 records during the hospital stay immediately preceding death.

Passage 2

your procedure, “SOP-DC-1, Transplant Tissue Exclusionary Criteria” (Revision 15, Implementation Date 11/29/22), used to determine donor eligibility and “Form F-DC-25 Sepsis Consult Flowchart” (Revision 1, Implementation Date 03/14/19), used to determine if an infectious disease consult is required, fail to include all clinical evidence and systemic responses to infection, if unexplained, of sepsis during the donor’s hospital stay immediately preceding death to appropriately evaluate a donor’s sepsis risk.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 1271
  • 21 CFR 1271.75(a)(1)
  • 21 CFR 1271.75(d)
  • 21 CFR 1271.350(b)
  • 21 CFR 1271.47(a)