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FDA Warning Letter Explorer
FDA warning letter · Biologics

Sperm Bank, Inc. dba Fertility Center of California

Issued · Posted by FDA

FDA published a close-out letter on Feb 19, 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

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, the following repeat anonymous semen donors were not tested for West Nile Virus (WNV) using an FDA-licensed nucleic acid test (NAT) donor screening test at the time of the first donation that is recovered within the June 1st through October 31st testing period.

Passage 2

Failure to collect a donor specimen for testing for relevant communicable diseases at the time of recovery of cells or tissue from the donor; or up to seven days before or after recovery (21 CFR 1271.80(b)). For example:

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 1271.75
  • 21 CFR 1271.3(t)
  • 21 CFR 1271.80(b)
  • 21 CFR 1271.45
  • 21 CFR 1271.47(a)
  • 21 CFR 1271.90(b)
  • 21 CFR 1271.90(c)