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FDA Warning Letter Explorer
FDA warning letter · Biologics

New Mexico Lions Sight Conservation Foundation, Inc. dba New Mexico Lions Eye Bank

Issued · Posted by FDA

Selected passages from the FDA letter

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

Passage 1

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)].

Passage 2

These procedures 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)