Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to test a specimen from an anonymous semen donor for evidence of infection due to relevant communicable disease agents [21 CFR 1271.80(a)]; and/or failure to retest anonymous semen donors at least six months after the date of donation of semen [21 CFR 1271.85(d)]; and/or failure to quarantine semen from anonymous donors until the retesting required under 21 CFR 1271.85(d) is complete [21 CFR 1271.60(a)]. For example:
Passage 2Failure to establish and maintain procedures for all steps performed in testing, screening, determining donor eligibility, and complying with all other requirements of Subpart C “Donor Eligibility” in 21 CFR Part 1271.45-1271.90 [21 CFR 1271.47(a)]. For example, your firm’s procedure *Human Cellular and Tissue-Based Products (HCT/Ps) Reproductive Tissue Bank Manual*, updated 6/6/2019, is deficient in that:
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 1271.85(d)
- 21 CFR 1271
- 21 CFR 1271.60(a)
- 21 CFR 1271.155
- 21 CFR 1271.80(a)
- 21 CFR 1271.75(a)(1)
- 21 CFR 1271.75(a)
- 21 CFR 1271.3(t)
- 21 CFR 1271.45
- 21 CFR 1271.47(a)
- 21 CFR 1271.3(r)
- 21 CFR 1271.3(r)(2)
- 21 CFR 1271.75
- 21 CFR 1271.80
- 21 CFR 1271.85(a)
- 21 CFR 1271.80(b)(2)
- 21 CFR 1271.90(b)
- 21 CFR 1271.90(c)