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FDA Warning Letter Explorer
FDA warning letter · Biologics

Louisville Reproductive Center

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 test a specimen from an anonymous or directed reproductive donor of cells or tissue, whether viable or non-viable, for evidence of infection due to relevant communicable disease agents [21 CFR 1271.85(a)]. For example:

Passage 2

Failure to test a specimen from a donor of viable, leukocyte-rich cells or tissue for cell-associated diseases [21 CFR 1271.85(b)(1)]. For example, semen was collected from directed donor **(b)(6)** on **(b)(6)**. However, the donor was not tested for Human T-lymphotropic virus, types 1 and 2 (HTLV-I and HTLV-II). Directed semen donor **(b)(6)** was determined “eligible” on July 12, 2024.

Citations in the original letter

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

  • 21 CFR 1271
  • 21 CFR 1271.60(a)
  • 21 CFR 1271.155
  • 21 CFR 1271.85(a)
  • 21 CFR 1271.85(b)(1)
  • 21 CFR 1271.75(a)(1)
  • 21 CFR 1271.45
  • 21 CFR 1271.47(a)
  • 21 CFR 1271.90(b)
  • 21 CFR 1271.90(c)