Green Valley Fertility Partners: FDA Warning Letter (Dec 3, 2025)

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 whether a donor is eligible based upon the results of donor screening in accordance with 21 CFR 1271.75 and donor testing in accordance with 21 CFR 1271.80 and 21 CFR 1271.85 [21 CFR 1271.50(a)]. The eligibility of two oocyte donors was determined and documented prior to the receipt of the results of donor testing for relevant communicable disease agents and/or the completion of the physical examination. For example:

Passage 2
Failure to omit the donor’s name and other personal information on the accompanying records [21 CFR 1271.55(c)]. For example, the names and birthdates of anonymous oocyte donors are included on the Summary of Records, which is considered an accompanying record as described in 21 CFR 1271.55(a).

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 1271.55(a)
21 CFR 1271.60(a)
21 CFR 1271.155
21 CFR 1271.85(a)
21 CFR 1271.75(d)
21 CFR 1271.75
21 CFR 1271.80
21 CFR 1271.85
21 CFR 1271.50(a)
21 CFR 1271.55(c)
21 CFR 1271.55(a)(1)
21 CFR 1271.90(b)
21 CFR 1271.90(c)